SUMMARY

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 Regulatory Affairs Specialist will play a key a key role in the implementation of post-market activities within Veryan. This is a fantastic opportunity, which will allow the successful candidate to gain international experience while working as part of a supportive, collaborative team in the state-of-the-art facility in Galway.

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 two years’ relevent experience in the medical device or pharmaceutical industry is required.
• Experience in Regulatory Affairs/Quality Assurance is preferred.
• Excellent attention to detail, communication skills, organisational skills, team working skills and problem solving skills is required.

• Responsible for the implementation of PMS activities identified under as defined in relevant Quality System procedures and Work Instructions.
• Participate in the implementation of Field Safety Corrective Action plan and associated activities.
• Support RA activities for Design Changes and Supplier-related changes including reporting assessment and generation of regulatory submissions.
• Support Gap Assessment process and associated process improvements.
• Provide support in onboarding new territories and re-registration activities in approved territories
• Support of PMA Annual Periodic Reporting system and approval of annual documentation for submission to FDA.
• Review and update of RA QMS procedures and work instructions and ensure activities are performed in line with these.
• Implement Technical File changes 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.
• Other RA activities, identified on the job, as required.