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Senior Regulatory Affairs Specialist

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.

Responsibilities:

  • 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.

Requirements:

  • 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!

To find out more about Real please visit www.realstaffing.com

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