Careers

Since Inception, MCRA, LLC. has been at the forefront of the neuro-musculoskeletal industry. When you work with MCRA, you join the leading advising firm and CRO to the orthopedic technology space. An organization at an exciting juncture - with continued expansion into various other medical/surgical specialties and indications.

Our team thrives in a fast-paced work environment that elicits creativity and advanced problem-solving ability. Our offices offer a collaborative, collegial atmosphere conducive to each person's development and success. Our team members are the heart of the organization's growth and therefore fully invested in. MCRA's unique team is comprised of various backgrounds of knowledgeable and passionate people and we invite you to be a part of our growth.

 

What We Offer You

  • A company with strategic vision and the focus to serve the medical device community.
  • Professional growth through training programs, challenging assignments, and the opportunity to collaborate with great individuals.
  • A supportive, experienced and collegial environment with people who value your experience and skills.

 

Hiring Initiatives

While MCRA is always interested in knowledgeable, energetic, and committed individuals, below is a list of our current needs. Click on any of the jobs below for a description. Please contact us at: careers@mcra.com with any questions or career inquiries.

 

Quality Assurance

  • Sr. Quality Engineer

    Job Title: Sr. Quality Engineer

     

                                                                                APPLY NOW

     

    JOB SUMMARY

    Candidates must have expert knowledge of 21 CFR Part 820, ISO 13485:2016, ISO 14971:2012, and the EU MDD or MDR. Knowledge of MDSAP, CMDCAS, and TGA is desirable. This position has the potential for growth into a more senior leadership role for the right candidate depending on experience and performance.

    RESPONSIBILITIES

    • Create, review, and improve:
      - Quality systems to meet regulations and standards.
      - DHFs, DMRs, and DHRs.
      - Technical files, design dossiers, ERCs, CERs, and STEDs.
      - FMEAs, DFMEAs, and PFMEAs.
      - Responses to FDA 483s and warning letters.
    • Plan and perform:
      - DHF and DHR remediations.
      - Internal, supplier, and due diligence audits.
      - Mock FDA inspections, including mock Pre-Approval Inspections.
      - Back- and front-room support for inspections and audits.
      - Remediations for Notified Body and Authorized Organization audits.
      - Gap assessments against regulations and standards, including ISO and IEC requirements.
      - Validations for device design, device software, manufacturing processes, and packaging.
      - Validations for quality system software, including for 21 CFR Part 11.
      - Validations for cleaning and sterilization.
    • Support or lead:
      - Design control projects, including design review meetings.
      - Complaint handling and CAPA processing.
      - Medical device/adverse event reporting to FDA, Authorized Representatives, and international regulatory bodies.
      - Corrections, removals, and recalls.
      - Nonconforming material and SCAR activities.
      - Supplier management programs.
      - UDI labeling, marketing, and submission to GUDID.
      - Communications with FDA, Notified Bodies, Authorized Organizations, Authorized Representatives, and          international regulatory bodies.

    QUALIFICATIONS

    • Minimum 7 years QA experience.
    • Minimum of 3 years auditing experience. 
    • Bachelor degree in scientific or related field.
    • Willingness to travel up to 50% (average) of working days.
    • Willingness to work with a variety of US and international clients.
    • Excellent writing skills.
    • Excellent people skills.
    • Detail-oriented, highly organized, independent, and self-motivated.
    • Experience with a variety of device types is desirable,
    • ASQ certification is desirable (CQA, CQE).

Regulatory Affairs

  • Senior Associate, Cardiovascular Regulatory Affairs

    Job Title: Senior Associate, Cardiovascular Regulatory Affairs

     

                                                                                APPLY NOW

     

    JOB SUMMARY

    The Senior Associate, Cardiovascular Regulatory Affairs will be a critical team member reporting to the Vice President of Cardiovascular Regulatory Affairs, to support regulatory strategy and submissions for the firm's cardiovascular clientele. The majority of projects will initially be based around the following product types: stents, heart valves, circulatory support devices, intravascular catheters, etc., and we expect for this position to develop into supporting additional technology areas (i.e: electrical cardiology devices) and other growing therapeutic concentrations of MCRA.

     

    RESPONSIBILITIES

    • Develop and execute regulatory services for client companies, including but not limited to:
      - Regulatory Strategy, Analysis, & Development
      - US Regulatory Submissions (510(k), IDE, PMA, IND, BLA, & IND)
      - Design, Review, and Implement Pre-Clinical Testing
      - Provide consultation on biological safety risk assessment, testing plans/strategies, test parameters and methods through understanding and implementation of analytical/chemical, in silico, in vitro, and in vivo testing methodologies in accordance with ISO Standards, FDA Guidance, and global regulatory requirements.
    • Work with other department heads and leadership team to guide the progress and development of the cardiovascular division as well as the regulatory department and company as a whole
    • Work collaboratively with other MCRA departments, including Clinical, Reimbursement, and Quality Assurance
    • Other projects

     

    QUALIFICATIONS

    • Bachelor of Science in a scientific discipline (biology, engineering, or a heavily technical writing based curriculum), MS, MSE, or PhD preferred
    • Minimum of 3-5 years of experience in Regulatory Affairs experience related to medical devices
    • The ideal candidate must have significant experience in one or more of the following device areas: Cardiac Diagnostics Devices, Cardiac Electrophysiology Devices, Circulatory Support Devices, Interventional Cardiology Devices, Implantable Electrophysiology Devices, Structural Heart Devices, Vascular Surgery Devices
    • Must have an understanding of mechanical engineering concepts and a biological background to assist with pre-clinical and clinical strategies, and be able to effectively communicate these strategies to internal team members and clients
    • Work experience must include assisting in the writing and/or reviewing of regulatory submissions
    • An understanding of clinical research and data analysis is desired
    • Possesses strong written and verbal communication and presentation skills
    • Strong research, analytical, critical thinking, and problem-solving skills
    • Excellent organizational and prioritization skills with the ability to handle multiple tasks and meet deadlines while working independently
    • PC/Technical skills - MS Office, Excel, Word, PowerPoint (Endnote experience a plus)
    • Effective interpersonal skills: shows confidence with subject matter and 'calm under pressure' approach and style
    • Strong professionalism and experience working with internal and client relationships at all levels
  • International Regulatory, CER Reviewer

    Job Title: International Regulatory, CER Reviewer

     

                                                                                APPLY NOW

     

    JOB SUMMARY

    This senior-level International Regulatory Affairs position will be a critical team member reporting to the Director, Clinical & Regulatory Affairs, to support international regulatory strategy and submissions for the firm's clientele. The majority of projects will be based around EU/International regulations; however, we expect for this position to develop into supporting additional global and domestic regulatory affairs projects.

     

    RESPONSIBILITIES

    • This individual will utilize their international regulatory affairs experience and technical background to review and oversee technical writing and Clinical Evaluation Reports (CERs) development by junior team members
    • Other duties as assigned

     

    QUALIFICATIONS

    • Bachelor of Science in a scientific discipline (biology, engineering, or a heavily technical writing-based curriculum), MS, MSE, or PhD preferred
    • Minimum of 5-7 years of experience in International Regulatory Affairs related to medical devices, including specific EU experience
    • Must have an understanding of mechanical engineering concepts and a biological background to assist with pre-clinical and clinical strategies, and be able to effectively communicate these strategies to internal team members and clients
    • Work experience must include the writing and/or reviewing of EU regulatory submissions, including but not limited to: Summary Technical Documentation (STED), design dossiers, technical files, Clinical Evaluation Reports (CER)
    • International experience/fluency with CE, Notified Body, ISO 13485, ISO 14971, MDR/MDD
    • Possesses strong written and verbal communication and presentation skills
    • Strong research, analytical, critical-thinking and problem-solving skills
    • Excellent organizational and prioritization skills with the ability to handle multiple tasks and meet deadlines while working independently 
    • Ability to lead and direct junior team members
    • Strong professionalism and experience working with internal and client relationships at all levels

Clinical Research

  • Senior Regional Clinical Research Associate

    Job Title: Senior Regional Clinical Research Associate

     

                                                                                APPLY NOW

     

    JOB SUMMARY

    The Senior Clinical Research Associate will be a critical team member reporting directly to the Direct of Clinical Affairs, to support clinical trial operations for the firm's clientele. Responsible for management of investigator sites and Clinical Research Associate (CRA) activities for assigned studies. The Senior CRA will execute Clinical Affairs functions in accordance with Good Clinical Practice (GCP) guidelines, Standard Operating Procedures (SOPs), and any other applicable regulatory requirements.

     

    RESPONSIBILITIES

    • Review research and study regulatory documents required for the implementation, monitoring, and evaluation of clinical trials
    • Design protocol-specific manuals, plans, and documents as needed
    • Ensure that monitoring activities (remote and on-site) are completed in accordance with company/client SOPs and Clinical Monitoring Plan
    • Conduct on-site and remote study monitoring and site management
    • Assist project manager with clinical study planning and management, as required
    • Develop and maintain positive relationships both internal and external to projects, including clients, team members, and site personnel (PIs, Study Coordinators, etc.)
    • Verify site qualifications and capabilities to conduct clinical studies
    • Ensure Trial Master File is accurate and complete throughout the lifecycle of the project
    • Prepare and conduct sire and CRA training for assigned clinical trials
    • Assist with site audits and site quality management activities as needed
    • Maintain current knowledge of GCP and FDA guidance as it relates to clinical research, as well as current clinical related developments in the assigned therapeutic areas
    • Assist with professional development for less-experienced Clinical Research Associates and Clinical Associates, as needed

    NOTE: This job description is not intended to be all inclusive. Employee may perform other related duties as to meet the ongoing needs of the organization

     

    QUALIFICATIONS

    • Bachelor of Science in a scientific discipline, BSN/RN, or similar; MS preferred
    • Minimum of 3-5+ years of clinical trial monitoring experience; Device Monitoring experience highly preferred
    • Comprehensive knowledge/fluency of GCPs and clinical monitoring procedures
    • Understanding of the therapeutic area for assigned clinical projects. Experience in orthopedics and/or cardiovascular is a plus
    • Experience using Electronic Data Capture (EDC) and clinical trial management systems
    • Attention to detail and the ability to work individually within a multi-disciplinary team as well as with extetnal partners and vendors
    • Possesses strong written and verbal communication and presentation skills
    • Proven track record of positive site and PI interactions
    • Strong research, analytical, critical-thinking and problem-solving skills
    • Excellent organizational and prioritization skills with the ability to handle multiple tasks and meet deadlines while working independently
    • PC/Technical skills - MS Office, Excel, Word, PowerPoint (Endnote experience is a plus)
    • Must be polished and professional
    • Effective interpersonal skills: shows confidence with subject matter and a 'calm under pressure' approach and style
    • Strong professionalism
    • Ability to read, write, speak, and understand English
  • Clinical Data Programmer

    Job Title: Clinical Data Programmer

     

                                                                                APPLY NOW

     

     

    RESPONSIBILITIES

    • Programs and validates TLF shells based on study needs in conjunction with biostatistics, clinical affairs, and regulatory affairs teams and populates the same per reporting needs
    • Programs and validates custom programs based on study needs for sponsor, biostatistics, data management, clinical affairs, and regulatory affairs teams. Reports may include, but are not limited to: query aging and status reports, AE reports, PD reports, etc.
    • Works with regulatory affairs and data management to ensure that data extracts and form population for DSMB and CEC meetings are accurate, reproducible and automated where possible
    • Assists in standardization of field naming and coding conventions
    • Develops and executes an SOP on central data cleaning and monitoring for all current and future studies
    • Develops and maintains additional SOPs as needed
    • Identify training for department staff as needed
    • Assist in the development, implementation, and delivery of departmental training programs
    • Interact with other departmental staff to ensure that project and department activities are successfully completed
    • Build and maintain EDC systems for clinical studies as needed
    • Assist with CRO vendor selection, evaluation, and oversight
    • Performs additional tasks as his/her background and expertise identifies as being of value

     

    QUALIFICATIONS

    • Master's degree (M.A./M.S.) or equivalent in Programming/Biostatistics or related field; relevant experience acceptable in lieu of Master's degree.
    • 10 years of experience in clinical research including significant experience in a technical environment using SAS for data management and/or biostatistics
  • Senior Clinical Data Manager (DC-Based)

    Job Title: Senior Clinical Data Manager 

     

     

    Location: Washington, DC

     

                                                                                APPLY NOW

     

     

    JOB SUMMARY

    MCRA is currently seeking a Senior Clinical Data Manager to work in our Washington, D.C. office. This position reports to the Associate Director of Data Management. The ideal candidate is forward thinking and self-motivated, and will proactively provide direction, leadership, and hands on support to other clinical data managers and colleagues for all assigned studies to ensure timely and high-quality data deliverables that are scientifically rigorous and accurate.

     

    RESPONSIBILITIES

    • Serve as lead data manager on data for multiple projects as assigned
    • Participate in protocol review focusing on data management needs and interests
    • Oversee day-to-day data management activities from study start-up through final database lock, including but not limited to development and curation of regulated documents, electronic data capture (EDC) set-up and management (including creation of eCRFs, performing UAT, visit map, reports, edit checks, and validation rules), data query management and resolution, and interim data locks and reporting
    • Act as data management liaison between study sponsors and internal groups
    • Draft and curate study related documents including the Data Management Plan, UAT Guide, eCRF Completion Guidelines, and related SOPs
    • Attend software related training and pass knowledge down to data management staff and other members of the study team
    • Follow all data management SOPs and suggest changes to improve department effectiveness as needed
    • Discuss data management topics in meetings for assigned studies
    • Lead scheduled data audits and draft reports of audit findings
    • Maintain proper documentation of data management activities
    • Read technical literature and participate in continuing education or professional associations to maintain awareness of current database technology and best practices
    • Perform other duties as assigned

     

    QUALIFICATIONS

    • Bachelor's degree in related field of study
    • 5+ years as a data manager and/or clinical database programmer or equivalent combination of education and experience in a CRO or related environment
    • Knowledge of Good Clinical Practices (GCP), Good Clinical Data Management Practices (GCDMP) and regulatory requirements related to clinical data management processes, documentation, and software
    • Knowledge and application of CDASH/CDISC a plus
    • Proficiency in Base SAS is preferred
    • Ability to adapt to rapidly changing situations and multiple requests
    • Ability and drive to learn new software and systems both with direction and independently
    • Experience writing and maintaining data management plans, CRF completion guidelines, detailed work instructions, and SOPs
    • Experience with OpenClinica, Medrio, Viedoc or other cloud-based EDC
    • Hands-on experience building studies in cloud-based EDC systems desired
    • Excellent communication, organization, time management, and interpersonal skills
    • Self-starter, able to communicate well within a team environment. Candidate will be proactive in managing and completing tasks in a timely fashion

Reimbursement

  • Director, Reimbursement Strategy (DC Metro Area)

    Job Title: Director, Reimbursement Strategy

     

                                                                                APPLY NOW

     

    JOB SUMMARY

    In a consultative capacity, the Director of Reimbursement Strategy, will work in close collaboration with the internal MCRA divisions - Clinical Research, Regulatory. and Reimbursement to establish systematic reimbursement, health economics, and market access strategies for client technologies throughout the product lifecycle, to ensure a competitive advantage and market access in a value-based healthcare market. The position will work directly with the Patient Access Programs and Reimbursement Policy team to develop and align reimbursement strategies, while overseeing their execution for new and novel therapies.

    This position would have U.S. responsibilities, with a growth opportunity into the global market.

     

    RESPONSIBILITIES

    • Develop Strategic Reimbursement Plans in support of Client needs for product commercialization, placement, and adoption
    • Partners with multiple internal and external stakeholders to deliver against client business and reimbursement strategies
    • Works to ensure market access requirement are understood and built into the product strategy throughout the product life cycle, and value propositions that reflect the needs of non-clinical stakeholders
    • Supports the development and execution of lifecycle evidence of value and market access strategies that enable market access and commercial success
    • Works collaboratively with MCRA's Patient Access Program, Payor team and Reimbursement Policy teams to develop and execute reimbursement strategies; ability to identify challenges and optimize tactics and course correct as necessary
    • Assists in driving evidence generation from clinical program and real-world evidence sources to substantiate and sustain technology value proposition
    • Maintains a strong pulse on the value propositions that will resonate with non-clinical stakeholders (payors, health technology assessment organizations, integrated delivery networks and systems, hospital value analysis committee), and oversees the development of clinical compendia, dossiers, and value packages; work closely with non-clinical stakeholders to effectively communicate technology value propositions
    • Oversee CMS policy proposals (MPFS, OPPS, IPPS) and analyze Client impact; communicate impacts to clients; work with team on development and submission of differential payments via new technology APCs, NTAPs, pass-through payments, MPFS modifications, etc.
    • Work closely with AMA, CMS, Clients and Specialty Societies to align on strategies for new or modifications of existing CPT, HCPS, and ICD-10 codes
    • Analyze Client products and their use within the current medical practice, comparisons to existing medical technologies, with emphasis upon coverage, coding, reimbursement, and health economic outcomes likely to influence market adoption
    • Conduct research and analysis regarding market opportunities for new healthcare technologies including pharmaceuticals, biotechnology, biologicals, medical devices, and diagnostics, with a focus on reimbursement
    • Facilitate the development and management of healthcare outcome and utilization (economic) studies, analyses, and publication initiatives
    • Represent MCRA and Clients, with Reimbursement stakeholders including, but not limited: industry representatives, payors, technology assessment organizations, healthcare providers and health systems, value analysis committees, professional societies, employer/consumer groups as well as trade associations
    • Other assignments as may be requested by the Vice President of Reimbursement

     

    QUALIFICATIONS

    • Excellent oral and written communication skills, with ability to clearly recommend and communicate complex reimbursement pathways and strategies to Clients
    • Strong analytical skills, with ability to understand complex payment and healthcare policies
    • Ability to think strategically, with development of reimbursement strategies that synergistically align with Client business objectives
    • Ability to effectively interact with internal and external stakeholders, including delivery of presentations to educate and provide consultation to Clients and inform a diverse set of functions, from the C-Suite level to Field Sales personnel
    • Self-directed individual able to manage Client engagements and projects with minimal supervision
    • 10+ years working within the healthcare arena, preferably within medical device industry or in a consulting organization, CMS, payor, specialty society organizations, technology assessment groups. Advanced knowledge and understanding of healthcare finance, payment mechanisms, payor processes for technology review and processes to establish coding, coverage, and payment for new and novel therapies, including mechanisms to support coding, coverage, and payment requirements of medical technology or biologics
    • Strong understanding of CMS payment methods and policy processes
    • Direct experience establishing coding, coverage, and payment for new and novel therapies across the product lifecycle.
    • Master's degree, advanced degree(s) preferred (MD, PhD, PharmD, etc.)

     

    SPECIAL REQUIREMENTS

    • Travel up to 40% (with possible international travel required)

Administrative

  • Administrative Assistant/Receptionist - DC Office

    Job Title: Administrative Assistant/Receptionist

     

     

    Location: Washington, D.C.

     

                                                                                APPLY NOW

     

     

    JOB SUMMARY

    This position will support the administrative operations of MCRA's Washington, DC office in alignment with MCRA's core values, the Company's desire to assist clients, the personal and professional goals of our people, and the growth of the company. MCRA believes in developing and growing its people, so the ideal candidate is looking to grow with a company. In this position, one could expect to experience a fast-paced environment working within a dynamic team of strong performers, This position is responsible for handling all front desk responsibilities in addition to providing general administrative and clerical support to the entire organization with a focus on the Washington, DC office.

     

    RESPONSIBILITIES

    • Primary telephone coverage for main lines
    • Welcome, greet, and direct all guests with a 'customer service' level of professionalism
    • Maintain the inventory and cleanliness of the conference rooms and kitchen
    • Order and organize office and kitchen supplies
    • Maintain office equipment and process service requests
    • Sort and distribute incoming mail and overnight deliveries. Process shipments
    • Arrange for courier services, meal catering, and various other services
    • Set up and assist with client and internal meetings
    • Provide a wide range of project assistance to supervisor as well as other team members
    • Assist with proposal and budget development

     

    QUALIFICATIONS

    • A Bachelor's Degree
    • Extremely proficient in Microsoft Outlook, Excel, Word, and PowerPoint
    • Articulate, and a good communicator
    • Excellent writing skills, verbal skills, and a kind manner
    • Attention to detail and great organizational skills
    • Consistent positive attitude daily, with the ability to prioritize and multitask 
    • Strong organizational skills and attention to detail
    • Ability to be comfortable and flexible in a constantly changing environment 
    • Easily adapt to new processes
    • Ability to handle sensitive and/or confidential information
    • Capacity to work independently, while also being a team player
    • Ability to manage and prioritize a busy workload
    • 3-5 years minimum experience working in an office setting highly preferred; 1-2 years minimum.