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Senior Regulatory Affairs Specialist

Location: Sligo, Republic of Ireland Salary:
Sector: Medical Devices, Engineering, 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 an initial 6 month hourly rate contract. The company specialise in the manufacture of wound care products and therapies. They are a family owned company, ensuring that they have a great culture onsite.

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 accordance with ISO13485.
  • Plan and prepare regulatory submissions for specific target markets for new products, product changes and re - registrations as required.
  • Communicate with notified bodies and other regulatory authorities to ensure product approvals in a timely manner.
  • Provide support to current product likes as necessary.
  • Perform additional duties as assigned.
  • Provide regulatory support to cross functional teams on site.

Requirements:

  • Degree in Science discipline.
  • Have a broad knowledge of global regulatory requirements.
  • Knowledge of medical device quality standards and practices.
  • Good communicable and interpersonal skills.
  • Proven problem solving skills.
  • 5+ year's experience within the medical device industry.

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

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

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