Summary:

This is a newly created opening looking for a Regulatory Affairs Technical Specialist for a global medical leader; multi-billion dollar business, a profitable division that designs, develops, and manufactures medical devices & consumables.

Responsibilities:

The Regulatory Affairs Specialist will provide regulatory support for a medical device manufacturer. This is a hands-on role that will oversee regulatory submissions from planning stages through execution, preparing for a global launch. In this role, you’ll adhere to timelines, budget, and quality, while working in a relatively autonomous, fast-paced role.

• Effectively plan, execute and manage deliverables for complex medical products, including 510(k)s, Pre-Submissions, CE-Mark Notified Body STED submissions and other global regulatory submissions

• You must be able to effectively interpret and apply regulatory requirements for launch into US, EU, Asia Pacific etc & provide guidance to the project teams for proper execution of submissions

• Perform review of promotional material for regulatory compliance according to country-specific requirements

Required Skills and Experience:

• 5+ years of Regulatory Affairs experience (501k); with experience in a medical device, medical instrument, or biotech industry (required)

• Experience with U.S. FDA 510k and/or PMA submissions and interaction with FDA reviewers required.

• Knowledge and experience with global registrations strongly preferred (EU, etc)

• RAC (Regulatory Affairs Certification) desired, not required

• QSR Design Control requirement knowledge, and ability to educate teams on these requirements

• Must possess a high level of critical and strategic thinking skills and be a detail-oriented team player with ability to influence multi-discipline teams and successfully negotiate with regulatory authorities.

• Bachelor of Science required; in a technical capacity (Science based - strongly preferred, others will be considered based on overall relevant experience)