Job Title
Regulatory Affairs Specialist
Overview
We are seeking a highly skilled Regulatory Affairs Specialist to join our organization. This is an exciting opportunity for a talented professional to make a real impact in the medical device industry.
Responsibilities
- Ensure compliance with regulatory requirements for Vigilance/MDR reporting in each territory.
- Support and lead improvements to the Regulatory Post Market System.
- Participate in the implementation of Field Safety Corrective Action plans and associated activities if required.
- Manage RA activities for Design Changes and Supplier-related changes, including reporting assessment and generation of regulatory submissions.
- Provide RA support to relevant Design Teams for Key Projects identified by our organization.
- Collaborate with other RA Specialists to achieve team success.
- Analyze trend data for regulatory reporting.
- Support the Gap Assessment process and associated process improvements.
- Manage and approve PMA Annual Periodic Reporting system documentation for submission to FDA.
Requirements
A degree level qualification in Engineering, Science, QA, or a related field is essential.
A minimum of 2 years experience at a regulatory level in the medical device industry is essential.
Experience of FDA guidance for sterile implantable products in premarket approvals is desirable.
Technical competency of ISO, ISO 14971, MDR 2017/745, and the FDA QSRs is a prerequisite.