RA Manager

Sigmar Recruitment
Employment Type
Not disclosed
Sigmar Recruitment logo

Regulatory Affairs Manager

About Your New Employer

Situated in Galway, this small but established medical device company has recently expanded its operations with many new projects. 

About Your New Job as an RA Manager:

  • You will assume responsibility as the key person for RA on what is a very new technology for the Galway site.
  • You, along with your team, will develop regulatory strategies.
  • You will perform activities associated with obtaining and maintaining regulatory approval to commercialize medical devices in selected target markets.
  • Specific emphasis for this role will be US FDA submissions.

What Skills You Need as an RA Manager:

  • Minimum 8 years’ experience in Regulatory Affairs, Design Assurance or similar role in a medical device company.
  • Level 8 qualified. MS, or PhD (Mechanical, Materials, Polymer, or Biomedical Engineering, or related technical field).
  • Knowledge and demonstrated practice of risk management methodologies as per EN ISO14971.
  • Working knowledge of FDA requirements including Quality System Regulation (21 CFR 820), the Medical Device Directive (93/42/EEC) and applicable harmonised standards and the ability to apply them in practice.
  • Previous experience with submissions to US FDA is a distinct advantage
  • Strong direct reports experience.

What’s Next?

  • Apply now by clicking the “Apply Now” button or call me, Emma Ward on Or if the job isn’t quite right but you are looking for something similar, please get in touch. We also have multiple Temp, FTC and Contract jobs available.