Our Regulatory team is growing every day! If you have regulatory experience and are interested in a consulting or contract role, please reach out to us.
In demand skills include:
- Experience working with regulators and Notified Bodies
- Ability to author submissions and other regulatory documents to obtain approval to bring new or modified products to market including but not limited to 510(k)’s, IDE’s, PMA’s, Technical Files, and Design Dossiers
- Combination Product regulation understanding a plus
- Current knowledge of U.S. medical device regulatory requirements and Quality System Regulations (QSR). Current knowledge of European Medical Device Directive, and other Global Market
- Interpret existing and/or new regulatory requirements as they relate to company products and procedures.
- Support marketing, R&D and manufacturing teams in regulatory assessment of proposed changes or product transfers