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Regulatory Affairs SaMD Lead, Medical Device

Location: United States,
Reference ID:

Our client is a unique, global Medtech company with a rich history of success in the areas of Advanced Wound Care, Ostomy, Critical Care, and Infusion with close to 10,000 employees worldwide.  They are in a new growth stage with incredible, disruptive technology that will bring great value in improving patient lives.  Our client is expanding their current portfolio with advanced technology that includes software development.  We are partnering to help bring on an SME or Regulatory Affairs Lead in the area of SaMD project development to provide regulatory guidance and lead stakeholders in clinical affairs, product development, and software development to provide guidance and direct input for submissions and developmental programs.

The Right Talent: 

BS in a relevant degree

5+ Years of RA or Quality experience in the Medtech industry

Strong experience with SaMD- 510 (k) submission experience preferred

Project Management experience leading teams cross-functionally

Understanding of US and EU pathways for regulatory submissions

Experience with the development and monitoring of software parameters such as cyber security and clinical data manipulation

Ability to travel as needed: 0-25%

Strong communication and problem-solving ability

 

 

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