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.

 

Regulatory

  • Technical Writer, Regulatory Affairs

    Job Title: Technical Writer, Regulatory Affairs
    Location: Washington, DC

     

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    JOB SUMMARY

    The Technical Writer, Regulatory Affairs, will be a critical team member reporting directly to the Director of Clinical & Regulatory Affairs, to support international medical device regulatory submissions for the firm's clientele.

    RESPONSIBILITIES

    • Develop and execute regulatory services for client companies, including but not limited to:
      - International Regulatory Submissions [Technical Files, Design Dossiers, Clinical Evaluation Reports (CERs)].
    • Work collaboratively with other MCRA departments, including Clinical, Reimbursement, and Quality Assurance.
    • Work with other department heads and the General Manager, to guide progress and development of the regulatory department and company as a whole.
    • Other Projects.

    QUALIFICATIONS

    • Minimum of 1-3 years of scientific technical writing experience related to medical devices OR education with strong research and technical writing curriculum.
    • Candidate with work experience should have experience assisting in the writing of regulatory submissions or scientific/clinical literature papers.
    • Bachelor of Science in a scientific discipline, MS preferred.
    • An understanding of clinical research and data analysis is desired.
    • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
    • 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 is a plus)
    • Must be polished and professional
    • Knowledge and experience utilizing research and providing statistical analysis
    • Effective interpersonal skills: shows confidence with subject matter, and maintains a 'calm under pressure' approach and style.
    • Strong professionalism
    • It is also recommended that the candidate have an understanding of engineering and a biological background to assist with pre-clinical and clinical strategies, and is able to effectively communicate these strategies to internal team members and clients.

     WORK HOURS

    • Full time position

Quality Assurance

  • Sr. Quality Engineer

    Job Title: Sr. Quality Engineer

     

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    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).

Clinical Affairs

  • In-House Clinical Research Associate

    Job Title: In-House Clinical Research Associate (CRA)
    Location: Washington, DC

     

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    Job Summary

    The In-House Clinical Research Associate will be a critical team member reporting directly to the Director of Clinical Affairs, to support clinical trial operations for the firm's clientele. Responsible for management of investigator site and Clinical Research Associate (CRA) activities for assigned studies. The In-House 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 and approve research and study regulatory documents required for the implementation, monitoring, and evaluation of clinical trials.
    • Review clinical protocols to ensure efficient collection of accurate data required for regulatory submissions.
    • Contribute to 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.
    • Assist project manager with clinical study planning and management, as required.
    • Develop and maintain positive relationships both internal and external to project, including clients, team members, and site personnel. (Pls, Study Coordinators, etc.).
    • Assist in the identification and recruitment of potential investigators and study sites, as needed.
    • Ensure Trial Master File is accurate and complete throughout the life-cycle of the project.
    • Assist with site 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.

    [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's degree (B.A./B.S.) in pharmacy, pharmaceutics, or a related scientific discipline.
    • At least 2 years of clinical trial experience. Monitoring experience preferred.
    • Comprehensive knowledge/fluency of GCPs and clinical monitoring procedures.
    • Understanding of therapeutic area for assigned clinical projects.
    • Experience using Electronic Data Capture (EDC) and clinical trial management systems.
    • Possesses strong written and verbal communication and presentation skills.
    • Strong research, analytical, critical-thinking, and problem-solving skills.
    • PC/Technical Skills - MS Office, Excel, Word, PowerPoint (Endnote experience a plus).
    • Ability to read, write, speak, and understand English.

    Work Hours

    Full time position.

Interested in Joining the MCRA Team?

Contact us with questions or any interests you may have that relate to our job openings at careers@mcra.com