Regulatory Affairs Senior Manager

Medtronic   •  

Sunnyvale, CA

Industry: Manufacturing

  •  

8 - 10 years

Posted 53 days ago

Careers that Change Lives

As Senior Manager, Regulatory Affairs you will manage multiple projects within Regulatory Affairs, both domestically and internationally. Use your extensive experience with medical devices including recently submitted 510k’s and completed Technical Files for the EU. Leadership experience is essential as this role requires frequent presentations and communications with senior leaders in the organization.


A Day in the Life

  • Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
  • Leads or compiles all materials required in submissions, license renewal and annual registrations.
  • Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
  • Monitors and improves tracking / control systems.
  • Keeps abreast of regulatory procedures and changes.
  • May direct interaction with regulatory agencies on defined matters.
  • Recommends strategies for earliest possible approvals of clinical trials applications.

Must Have: Minimum Requirements

  • Bachelor degree in scientific discipline required or advanced degree with a minimum of 5 years of relevant experience
  • 7 years experience in Regulatory Affairs medical device arena
  • 5+ years of managerial experience
  • Demonstrated experience in preparing global regulatory submissions - PMAs, IVE's, 510(k).
  • Experience authoring 510(k).
  • Management experience required/Exceptional leadership capabilities.
  • Strong interpersonal and analytical skills
  • Excellent written and oral communication skills.
  • Excellent organizational and multi-project management skills.

Nice To Have

  • Advanced Degree in Regulatory Affairs
  • RAC Certifiied
  • 190000ZL