Description:
Veryan Medical is a fast-paced, rapidly growing medical device company offering a highly differentiated solution in vascular interventions. We share a commitment, a passion, and a vision for the contribution Veryan makes to innovation in interventional medicine.
Our team powers Veryan’s business. Whether sales representatives, design engineers, quality engineers, or clinical study managers, our people bring an unmatched expertise in each of their fields that both inspires and challenges.
Veryan’s culture of innovation helps each individual develop both professionally and personally, and our culture of respect means that we all work in a collaborative, empowering, and exciting environment. We are committed to excellence through our patient-centric approach, and we pride ourselves in our integrity of doing what is right and doing what we say.
Reporting to the Senior Regulatory Affairs Manager, the Senior Regulatory Affairs Specialist- Post Market will play a key role in the implementation of post-market activities within Veryan. This is a fantastic opportunity, which will allow the successful candidate to add real value to the future success of Veryan while working as part of a supportive, collaborative team in the new state-of-the-art facility in Galway.
Job Requirements
Principal 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-market activities.
- Approve all change notices (CC/CCNs) with input from RA Manager as required.
- Manage EUDAMED activities for Post Market activities.
- Support introduction to new markets, CAPA activities, and internal and external audits as required.
Education & Training
- Bachelor’s degree (Level 8 NFQ) or relevant Diploma in Engineering/Science or related discipline.
- Where Degree / Diploma is from another area, relevant experience may be accepted.
Experience & Skills
- A minimum of five years’ relevent experience in the medical device industry is essential.
- Experience in the area of Regulatory Affairs/ Quality Assurance preferred.
- Excellent attention to detail and ability to produce reports at a high standard.
- Proven skills in the area of communication, organisation, computer literacy, problem solving and collaboration.