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Senior Regulatory Affairs Specialist - Remote

Job Seekers Ireland Science Life Science

Job Summary

  • Athlone
  • Permanent
  • BBBH797775
  • Jan 19, 2022
  • Competitive
Job Description

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.

Responsibilities include:

  • 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.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.

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Consultant Details

Consultant Details

Aoife O'Driscoll
Aoife O'Driscoll
  • Consultant
  • +353 (0) 21 2300300
  • aodriscoll@morganmckinley.com