Medical Writer, Regulatory Affairs

United States, |

Medical Writer – Regulatory Affairs

 

Peripheral and/or specialized implants are very challenging products and challenging products need talented writing skills to ensure accuracy and compliance throughout the breadth of the regulatory/clinical process.

 

In a constantly changing landscape of Regulations, the most successful companies have a strong core of Regulatory Professionals and we are helping our client build onto theirs. Your knowledge of how to ensure the accuracy of clinical claims and provide expertise in Risk will be paramount to your success as they may impact the breadth of the product line. Your knowledge base in 13485, 14971, MDD/EU MDR and CMDCAS is, of course critical as you’ll be working with those guidance’s every day.

We are looking for strong experience working in an FDA regulated environment with a clinical focus. We’ll look for you to demonstrate your analytical and technical writing skills. This role is not a pigeonhole but real opportunities to learn and grow exist here.

Still interested?

 

RESPONSIBILITIES:

  • Development and maintenance of Clinical Evaluation Reports (CERs) in compliance with MedDev 2.7.1
  • Development and maintenance of white papers for products manufactured by the client
  • Review clinical claims made in promotional material to ensure compliance to good practices
  • Provide clinical expertise for risk management activities and health hazard evaluation activities
  • Development and maintenance of PMS and PMCF activities

REQUIREMENTS:

  1. BS/BA in a Scientific or Clinical discipline with 3-5 years’ experience, or a PhD in a related field, working in an FDA regulated environment
  2. Regulatory Affairs Certification is preferred
  3. In-depth knowledge of applicable regulations with a working knowledge of MDD/EU MDR and CMDCAS highly valued
  4. Clinical writing and/or review experience required
  5. Orthopedic experience highly valued
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