Manager Regulatory Affairs

Smaller sized medical device company is looking for a Regulatory Affairs Manager to lead all regulatory activities related to existing products, new products being developed and work with the FDA, EU and Japan on new product submissions.

The company just relocated within the Boston area to accommodate their rapid growth and they are expanding their Regulatory team.

This is an opportunity to:

  • Join a fast moving, dynamic medical device company.

  • Provide guidance to an onsite R&D group.

  • Be responsible for all 510Ks and IDEs etc.

  • Work directly with the FDA.

  • Assist new products through clinical studies.

  • Focus on both international and domestic markets.

  • Manage and mentor an RA Associate.

This position does have a direct report.

Boston area.