Senior Regulatory Affairs Specialist

Location: Sligo, Republic of Ireland Salary:
Sector: Medical Devices, Quality Assurance (QA), Regulatory Affairs (RA) Type: Contract

One of my key clients are currently seeking an experienced Regulatory Affairs Specialist to join their team on a 6 month hourly rate contract. The company are a global medical device company, and specialise in the manufacture of wound care products. They are a family owned company, ensuring they have an excellent culture on site, and are renowned for being a great place to work.

Role: Regulatory Affairs Specialist

Location: Sligo

Contract: An initial 6 month hourly rate contract

Your role as a Regulatory Affairs Specialist will be to aid in the development of Regulatory strategies, while obtaining and maintaining regulatory approval to commercialise the devices.


  • Maintain an excellent understanding of global medical device regulations, in accorandance with ISO13485 standards.
  • Ensure a thorough understanding of products as they are assigned.
  • Plan and prepare regulatory submissions for specific target markets for new products, changes in products and re registrations as needed.
  • Maintain registration information and obtain re registration approvals in advance of licence expirations.
  • Serve as a liaison / representative for the Regulatory team to other cross functional teams including Quality, R&D and Manufacturing teams.
  • Maintain and organise appropriate regulatory records to demonstrate compliance with applicable regulations.
  • Perform additional duties as assigned.


  • Degree in Science / Engineering disciplines.
  • Have a good working knowledge of medical device or pharmaceutical quality standards.
  • Ideally have a knowledge of global regulatory requirements in accordance with the ISO13485.
  • Proven problem solving skills.
  • Proven organisation skills.
  • Good communication and interpersonal skills.

This is an excellent opportunity for an experienced Regulatory Affair Specialist to join a global medical device company in Ireland.

No CV ready? Not sure yet? Feel free to contact me for further details!

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Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales