- BBBH797775 Jan 19, 2022 Competitive
An exciting new opportunity to join a Medical Device company with a huge portfolio and scope to further and progress your career with exposure to different projects.
This person will enjoy a fast paced and challenging role which brings great rewards. The role is based in the midlands but there is flexibility to work from anywhere in Ireland with limited on-site travel depending on location. Excellent package on offer.
This person will have minimum 3 years working in a Regulatory Affairs Specialist role, coming from Medical Device with excellent technical writing skills. They will work as part of a team on a particular business unit but will get excellent opportunity to be involved in varying portfolios down the line. You will have a relevant science/engineering degree and ideally but not essentially have knowledge of risk, clinical or biocompatibility. Excellent knowledge and working experience of QA, RA, and R&D essential.
- Develop strategies and submissions for complex projects.
- Deal with issues relating to regulatory documents, submission, investigations, product development and regulatory agency interaction.
- Management of all technical documentation.
- Manage global regulatory impact assessments and updates to global regulatory procedures.
- Review and assess current change control activities for impact on current regulatory filings.
- Apply Technical writing skills to clearly relay technical information.
- Ensuring continual Quality system systems compliance by adhering to internal requirements.
- Support R&D projects, input, and approval for new product introductions.
- Work cross functionally to recommend solutions across Engineering, Quality and Operations.
- Support inspections readiness and on-site regulatory inspection.
- Engage with regulatory authorities during the development and review process of submission approval as well as during audits.
- Mentor and develop staff members.
If this role is of interest, click 'apply now'.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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