Clinical Regulatory Affairs Specialist

Dallas, Texas | Quality Assurance / Safety

Peripheral and/or specialized implants are very challenging products and challenging products need talented regulatory people from design through to commercialization.

 

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. Whether leading the strategy, or implementing it, whether for NPD or existing products, your contributions will 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 3 years’ experience at minimum working in an FDA regulated environment. Even with the required experience your analytical and technical writing skills are critical and we’ll look for you to demonstrate those. From review of engineering and marketing materials to labeling and including market release activities this role is not a pigeonhole but real opportunities to learn and grow.

Still interested?

 

RESPONSIBILITIES:

  • Development and maintenance of Clinical Evaluation Reports (CERs) in compliance with MedDev 2.7.1.
  • Development and maintenance of white.
  • 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 a minimum of 3 years’ experience and that must be in an FDA regulated environment
  2. Regulatory Affairs Certification is highly desired
  3. Orthopedic experience highly valued
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