Job Details
Posted 1 August, 2026
Job Id: 629736
Senior Regulatory Affairs Consultant
Job Description
Level: Senior Manager to Associate Director
Location: Onsite – TX
Duration: 5- 6 months
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
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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