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

  • Associate, Regulatory Affairs

    Job Title: Associate, Regulatory Affairs
    Location: Washington, DC

     

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    JOB SUMMARY

    The Associate, Regulatory Affairs will be a critical team member reporting to the Director of Regulatory Affairs, to support US and International Regulatory strategy and submissions for the firm's clientele. The majority of projects will be initially be for companies in orthopedics (general orthopedics, sports medicine, spine, biologics, trauma, new developing niches) and we expect for this position to support additional technological areas such as cardiovascular and other growing therapeutic concentrations of MCRA.

    RESPONSIBILITIES

    • Develop and execute regulatory services for client companies, including however not limited to:
      - Regulatory Submissions [510(k), IDE, PMA, IND, BLA, & IND].
      - International Regulatory Submissions [Technical Files, Design Dossiers, Clinical Evaluation Reports (CERs)].
      - Regulatory Strategy, Analysis, & Development.
      - Design, Review, & Implement Pre-Clinical Testing.
    • 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 experience in Regulatory Affairs experience related to medical device, OR post-graduate education with strong research and technical writing curriculum.
    • Candidate should have experience assisting in the writing of regulatory submissions.
    • Bachelor of Science in a scientific discipline, MS or PhD preferred.
    • An understanding of clinical research and data analysis, as well as international regulatory experience including developing Technical Files, Design Dossiers, and Clinical Evaluation Reports (CERs) is desired.
    • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners.
    • Possesses strong written (including medical writing) and verbal communication and presentation skills.
    • An understanding of mechanical engineering and a biological background to assist with pre-clinical and clinical strategies, and the ability to effectively communicate these strategies to internal team members and clients.
    • Domain-specific regulatory expertise in orthopedics (general orthopedics, sports medicine, spine, biologics, trauma, new developing niches) preferred.
    • 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).
    • Must be polished and professional
    • Knowledge and experience utilizing research and providing statistical analysis.
    • Effective interpersonal skills; shows confidence with subject matter and 'calm under pressure' approach and style.
    • Measurable experience working with C-Level and Senior management.
    • Strong professionalism with customer relations and managing client relationships.

     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).

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