Job Summary:
Senior Regulatory Affairs Specialist
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Job Description:
We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team. As a key member of our regulatory department, you will be responsible for implementing PMS activities, approving Vigilance/MDR reporting, and supporting the development of Regulatory Post Market System improvements.
In this role, you will participate in Field Safety Corrective Action plan and associated activities, manage RA activities for Design Changes and Supplier-related changes, provide RA support to relevant Design Teams, and manage trend data for regulatory reporting.
You will also support Gap Assessment process and associated process improvements, manage the PMA Annual Periodic Reporting system, and approve annual documentation for submission to FDA. Additionally, you will manage post-market scheduling of RA activities, review and approve RA QMS procedures and work instructions, and implement Technical File updates arising from changes.
The ideal candidate will have a degree level qualification in Engineering, Science, QA, or related field, with minimum 5 years experience at senior regulatory level in medical device industry.
Experience in creation of regulatory submissions for premarket approval is required, as well as technical competency of ISO13485:2016, ISO 14971, MDR 2017/745, and the FDA QSRs.
This role involves working closely with cross-functional teams and requires strong analytical and communication skills. The successful candidate will have excellent technical knowledge of regulatory requirements and a degree in a relevant field.