Job title: Senior Regulatory Affairs Specialist Location: Parkmore, Galway. 1-2 days a week on site Benefits: Top salary, Bonus, pension, healthcare, hybrid working Overview: My client are a fast-paced, rapidly growing medical device company offering a highly differentiated solution in vascular interventions. With a culture of innovation helping each individual develop both professionally and personally, and our culture of respect means that they all work in a collaborative, empowering, and exciting environment. Reporting to the Senior Regulatory Affairs Manager, the Senior Regulatory Affairs SpecialistPost Market will play a key role in the implementation of post-market activities. This is a fantastic opportunity, which will allow the successful candidate to add real value to the future success of the company. Responsibilities: - Responsible for the implementation of PMS activities identified under Post Market Regulatory Reporting and change assessment as defined in relevant Quality System procedures and Work Instructions. - Approval of Vigilance/MDR reporting as defined in each territory. - Support and lead Regulatory Post Market System improvements. - Participate in the implementation of Field Safety Corrective Action plan 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 Veryan. - Provide support to other RA Specialists in achieving success for the team. - Manage and support trend data for regulatory reporting. - Support Gap Assessment process and associated process improvements. - Management of PMA Annual Periodic Reporting system and approval of annual documentation for submission to FDA. - Manage post-market scheduling of RA activities for timely completion and submission to regulatory authorities. - Review and approval of RA QMS procedures and work instructions and ensure activities are performed in line with these. - Implement Technical File for updates arising from changes. - Identify and awareness of new regulation requirements or changes required to be considered by Veryan Medical for regulatory compliance in all territories for postmarket activities. Requirements: A degree level qualification in Engineering, Science, QA, or related field is essential. A minimum of five years experience at a senior regulatory level in the medical device industry is essential. A minimum of five years experience in the creation of regulatory submissions for premarket approval is required. 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. Does this sound like your next career move? To apply and For more info forward your application to the link provided or contact me on OR Skills: Regulatory Affairs Medical Device Quality Benefits: Bonus, pension, healthcare, Hybrid working
