RA Specialist

This organisation are globally renowned within the medical device industry sector. The organisation produce numerous medical devices types ranging from surgical textiles used in catheter cuffs and heart valves to PTA/PTCA balloons for stint and drug delivery. In Ireland they manufacture angioplasty catheters that are used to unblock arteries in both coronary and peripheral procedures. The organisation are experiencing rapid growth at this site in Ireland, where they employ 400 individuals, due to the introduction of a new product. As such they require a Regulatory Affair Specialist to join their team.

The Position:

The Regulatory Affairs Specialist is a key member of the Regulatory Affairs and Quality Team. You will be responsible for utilising your regulatory expertise to support operations throughout the organisation. Additional responsibilities will include;

  • Prepare FDA submissions, along with managing European and international technical files, dossiers and registrations.
  • Participate in product development/line extension teams as required in order to ensure that the product is in compliance with all internal and external regulatory requirements.
  • Develop, document and implement a regulatory submissions plan. This plan would be around product development/line extension goals.

The Person:

The successful Regulatory Affairs Specialist will have a 3rd level technical/ Science qualification, with a minimum of 3 years experience in a regulatory role within the medical device or pharmaceutical industry sectors.

An understanding of US, European and International standards and regulations covering medical devices is essential. As are the ability to utilise problem-solving techniques and display excellent interpersonal skills within a team environment.

This role offers an excellent remuneration package, along with superb working conditions.

To learn more apply online or call Conor Britchfield at HRM on +353 1 6321870.

Salary: On Application Location: Wexford