Senior Regulatory Affairs Consultant, Class III Medical Devices
Overview
You will own regulatory product lifecycle activities for high-risk Class III medical devices at a Texas-based medical device company. Working 100% onsite in Austin, you will ensure ongoing compliance with FDA and EU MDR/MDD requirements. Your work will directly support PMA maintenance, FDA Annual Reports, and international registrations. This role offers hands-on regulatory execution in a collaborative, fast-paced environment.
What You'll Do9
- 1Drive Class III product lifecycle activities from regulatory perspective through end of year.
- 2Maintain compliance with internal procedures and applicable regulatory requirements.
- 3Support internal processes to maintain compliance with agency approvals.
- 4Author internal regulatory documentation aligned with company procedures and regulatory requirements.
- 5Assess product and process changes and complete regulatory impact assessments.
- 6Support PMA, MDR, and MDD file maintenance for high-risk products.
- 7Prepare the FDA Annual Report.
- 8Support international registrations and renewals as needed.
- 9Coach junior RA team members on regulatory best practices.
Requirements7
- 1Senior Manager to Associate Director level Regulatory Affairs experience.
- 25+ years in medical device regulatory affairs with strong Class III device experience.
- 3Hands-on experience with PMA lifecycle maintenance and EU MDR/MDD documentation.
- 4Proven ability to complete regulatory impact assessments for product and process changes.
- 5Experience preparing FDA Annual Reports.
- 6Knowledge of international registration and renewal processes for medical devices.
- 7Strong communication and coaching skills for guiding junior team members.
Salary Insight
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