Regulatory Affairs Specialist (Post-market Vigilance / Adverse Event) Full time - Permanent Galway- Hybrid
We have an exciting opportunity for a Regulatory Affairs Specialist (Post-market Vigilance / Adverse Event) to join Veryan Medical!
Summary
Veryan Medical is a fast-paced, rapidly growing medical device company offering a highly differentiated solution in SFA 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.
The RA Specialist will play a key role in Veryan's current projects and Regulatory team.
This is a great opportunity which will allow the successful candidate to take the next step in their career in terms of responsibility 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 timely submission of US MDR and European Vigilance Reports to external regulatory agencies and to the Notified Body where required for Vigilance reporting originating in any EU countries.
Support the response to any queries received from regulatory agencies in relation to incidents reported or post market regulatory reports submitted.Assist in the preparation/filing of PMS reports to relevant regulatory authorities, as required.Support compilation of post approval study (PAS) progress reports and IDE progress reports for filing with FDA.Responsible for clinical study adverse event reporting to regulatory authorities.
Participate as a clinical study team member in providing oversight of adverse event reporting, complaint handling and provide appropriate support to the clinical teams as required.Provide regulatory oversight of Clinical Events Committee meetings adjudication of events reported from clinical studies with potential impact to previously documented regulatory reporting decisions through review of meeting minutes.Support risk management, risk analysis and health hazard analysis associated with post-market vigilance/MDR information.Support co-ordination of field safety corrective actions.Support both internal and external audit activities and interface directly with auditors/inspectors.Support any CAPA activities as required.Other duties as required by the Company. Education & Training Diploma or Bachelor's degree (Level 8 NFQ) in Engineering/Science or related discipline.
Industry experience will also be considered.Experience & Skills Minimum 3-5 years' experience in vigilance, MDR and adverse event reporting within the medical devices industry, ideally in the cardiovascular field.Strong communication skills both written and verbal.Excellent interpersonal skills.Ability to prioritise project tasks and meet deadlines.Benefits of Working with Veryan: Competitive salary and bonus.Pension scheme with generous employer contributions.Private medical insurance for you, spouse / partner and dependents.Paid sick leave.Group life cover.Annual leave of 23 days plus bank holidays increasing with service.Active Sports and Social Committee with a schedule of events taking place during the year.Hybrid working.Flexible start and finish times.Opportunities for further education, training and development.Company Values CollaborativeInnovativeEmpoweringPatient-centricActing with Integrity
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