Regulatory Affairs Manager

Summary

The Regulatory Affairs Manager directs the activities of regulatory teams involving regulatory submissions, strategies, and projects. This role reports to the Regulatory Affairs Director.


Full Description

Key Accountabilities:

• Manage development and implementation of regulatory strategies for RA staff for Class I, II, and III devices through interface with health authorities including FDA, Notified Bodies, and Competent Authorities and cross functional team members
• Provide leadership, personnel development, coaching, and mentoring to staff
• Provides regulatory guidance to site
• Ensures adherence to AMS procedures for the timely approval of new products. Oversees the preparation and maintenance of regulatory submissions including US 510(k), IDE, and PMA files and EU Technical Documentation
• Manages site recall decision process
• Ensures adherence to vigilance reporting procedures
• Manages internal and external audits including health authority audits such as Notified Bodies, competent authorities, US FDA etc

The ideal candidate will have:

• A minimum of a Bachelor’s Degree is required. An advanced degree (Masters, PhD, PharmD, etc.) is preferred
• A minimum of 8 years direct Regulatory Affairs experience
• People management experience of at least 2 direct reports
• In-depth understanding of global medical device regulations and demonstrated direct experience with US Class II, III and EU Class IIb, III medical devices including 510(k), IDE, PMA and EU Technical Documentation
• Excellent written and oral communication, technical writing, and editing skills
• Position may be based remotely
• Position may require up to 20% travel