Science
Senior Regulatory Affairs Specialist
- TypePermanent
- SalaryNegotiable
- LocationDublin
- Published31 Jan 2024
- Ref#BBBH13999
- Apply now!
About the Client: Azon is delighted to be partnered with an up and coming clinical organisation in the development of a cutting edge device through design development, verification, clinical trials, validation and regulatory approvals.
Location: Dublin – Fully remote and hybrid option available
About the Role:
- Provide regulatory guidance to product development team, working closely with cross-functional team members to develop and implement the regulatory strategy.
- Lead the development, submission and maintenance of high quality clinical and regulatory files to the relevant regulatory agencies, ensuring successful approval.
- Support the creation and maintenance of product design and technical documentation in compliance with the relevant regulations and standards.
- Participate in discussions with regulatory authorities.
- Assist company preparation for inspection by notified body and regulatory authorities.
About the Person:
- BSc minimum in scientific discipline.
- 4+ years of related experience in Regulatory Affairs in an ISO13485 Medical Device environment.
- Experienced in the preparation of documentation for submissions to regulatory bodies.
- Experience in project management in technical activities.
Amara McCalliog
Principal Recruitment Consultant - Life Sciences
Amara, based in our Dublin office is the Principal Recruitment Consultant for Life Sciences and specialises in QC, R&D and technical based roles. Amara obtained a BSc. in Biology and Applied Mathematics at Maynooth University. Following her studies, Amara gained invaluable laboratory experience through her roles as a Laboratory Technician and Deputy Team Lead of a Molecular Biology Department. From here, Amara moved into recruitment of laboratory based roles and can offer permanent, contract and temporary recruitment solutions.