Job title: Senior Regulatory Affairs Specialist
Location: Parkmore, Galway. 1 day 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.
- 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.


Requirements:

• A degree level qualification in Engineering, Science, QA, or related field is essential.
• A minimum of 3 years experience at regulatory position in the medical device industry is essential.
• Experience of FDA guidance for sterile implantable products in premarket approvals is desirable.
• Technical competency of ISO13485:2016, ISO 14971, MDR 2017/745, and the FDA QSRs is a prerequisite.