Connecting...

Senior Regulatory Affairs Specialist

Job description

Senior Regulatory Affairs Specialist                  

Responsibilities: 

  • Define global regulatory pathways for projects across the EU, US and elsewhere internationally with regard to product launches and changes.
  • Prepare for regulatory submissions such as FDA, Notified Bodies, Health Canada and other regulatory authorities
  • Work together with international regulatory agencies on products and projects, answering any relevant questions on issues with products and change controls.
  • Provide support for commercialized products by reviewing labelling, promotional materials, and product and documentation changes per policy and procedure.
  • Work cross functionally internally providing technical guidance and regulatory mentoring to Design Assurance, Quality and Manufacturing teams.
  • Participate and assist with FDA facility inspections, Notified Audits and other Governmental inspections.

 Requirements: 

  • Bachelor’s degree in STEM related field with working knowledge of U.S. FDA regulations, the Medical Devices Directive (93/42/EEC, as amended), the Medical Device Regulation (2017/745, as amended), and various Quality System Standards/Regulations/Laws, including but not limited to ISO 13485 and MDSAP.
  • 4 or more years’ experience in regulatory affairs or related type positions.

 

To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E:   jporter@sigmar.ie  

All applications will be treated with the strictest of confidence.  Sigmar will never forward your CV to a third party without prior consent

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.