EU MDR Specialist in Braintree, MA at Eliassen Group

Date Posted: 12/29/2020

Job Snapshot

Job Description

This consultant will be responsible for updating technical files and design dossiers to meet the new EU MDR requirements.  They will be responsible for reviewing Tech Files and then conducting the hands on upgrades required to transition from MDD to  EU MDR compliance.

Experience with the following would be helpful:

  • Clinical Evaluation Reports (CER)
  • RAPS
  • Familiarity with ISO 13485, ISO 14971 and IEC 60601

This is a REMOTE POSITION.

No 3rd parties please.

key words: Medical Device, Regulatory, EU MDR, MDD

Job ID: 320431

About EG Life Sciences:

Founded in 2010, EG Life Sciences is a national professional services firm that delivers flexible, scalable solutions for Medical Device, Pharmaceutical, and Biotechnology companies. We provide the resources they need to meet the unique challenges of FDA regulations and submissions. Our team is comprised of leaders who are clinical development professionals and veterans of the FDA-regulated healthcare industry with significant technical knowledge and expertise. The practice is also supported by a seasoned technical recruiting and project delivery/support team. This combination enables us to quickly deliver value-driven consulting, interim leadership, technical project management, and time and material and project-based staffing solutions.

Eliassen Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

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