Job title: Senior Regulatory Affairs Specialist – Post market
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 Specialist[1]Post 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 post[1]market 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 ISO13485:2016, ISO 14971, MDR 2017/745, and the FDA QSRs is a prerequisite.