Regulatory Affairs Specialist II
Full time- Fixed Term (Maternity Contract)
Galway- Hybrid
We have an exciting opportunity for a Regulatory Affairs Specialist II to join Veryan Medical!
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 II 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.
Job Requirements
Principal Responsibilities
- Responsible for the implementation of PMS activities identified under as defined in relevant Quality System procedures and Work Instructions.
- Support and lead Regulatory Post Market System improvements.
- Participate in the implementation of Field Safety Corrective Action plan and associated activities.
- 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.
- 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 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.
- Other RA activities, identified on the job, 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 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.
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
- Collaborative
- Innovative
- Empowering
- Patient-centric
- Acting with Integrity
We retain your details for a period no longer than required for the application process. This allows us to process your details for the purposes of submitting, evaluating, and progressing your application, and any feedback thereafter. If you believe that any of these purposes are overridden by your interests, or fundamental rights and freedoms, please contact us at [email protected].
When you initially contact us, we retain your data under Article 6(1)(a) Consent, and you have the right to request that this data is deleted. During the application period, we process your data under the legal basis of Article 6(1)(b) Performance of a Contract.
Veryan's recruitment privacy notice is available at https://veryanmed.com/wp-content/uploads/2024/09/Veryan-applicant-privacy-notice-final.pdf
