Senior Reg Affairs Specialist - Post Market
Job Title: Senior Regulatory Affairs Specialist – Post Market
Location: Hybrid working arrangement, with 1-2 days a week on-site in Parkmore, Galway.
Benefits: Competitive salary, Bonus, pension, healthcare, and flexible working arrangements.
Overview:
Our client is a rapidly growing medical device company offering a unique solution in vascular interventions. They have a culture of innovation that helps individuals develop professionally and personally, as well as a collaborative, empowering, and exciting work environment. Reporting to the Senior Regulatory Affairs Manager, the Senior Regulatory Affairs Specialist will play a key role in implementing post-market activities.
Responsibilities:
* Implement PMS activities identified under Post Market Regulatory Reporting and change assessment as defined in relevant Quality System procedures and Work Instructions.
* Approve 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.
* Support other RA Specialists in achieving team success.
* Manage and support trend data for regulatory reporting.
* Support Gap Assessment process and associated process improvements.
* Manage PMA Annual Periodic Reporting system and approve annual documentation for submission to FDA.
* Manage post-market scheduling of RA activities for timely completion and submission to regulatory authorities.
* Review and approve 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 maintain awareness of new regulation requirements or changes required to be considered by Veryan Medical for regulatory compliance in all territories for post-market activities.
Requirements:
* A degree-level qualification in Engineering, Science, QA, or a 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 creating 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.