Sr Regulatory Affairs Consultant

Job Title: Senior Regulatory Affairs Consultant

Location: Austin, TX – 100% Onsite

Duration: 12+ months with possible extension

Overview:
Medical device company in Texas is looking to add a Senior Regulatory Affairs Consultant to support high-risk Class III medical device product lifecycle activities. Candidates must have strong Class III medical device experience and be comfortable supporting hands-on regulatory execution in a fast-moving environment.

Key Responsibilities:
• Support the site with Class III medical device product lifecycle activities through end of year
• Ensure ongoing compliance with internal procedures and applicable regulatory requirements
• Support internal processes to maintain compliance with agency approvals
• Author internal regulatory documentation in alignment with company procedures and regulatory requirements
• Assess product and process changes and complete regulatory impact assessments
• Support PMA, MDR, and MDD file maintenance for high-risk products
• Assist with preparation of the Annual Report for the US FDA
• Support international registrations and renewals, as needed
• Provide basic coaching and guidance to more junior RA team members, as needed

Ideal Background:
• Senior Manager to Associate Director level Regulatory Affairs consultant
• Strong Class III medical device experience required
• Experience with PMA lifecycle maintenance, EU MDR/MDD documentation, regulatory impact assessments, and FDA annual reporting
• Comfortable working onsite and supporting execution-level regulatory work