Regulatory Affairs Specialist

Location: Limerick, Republic of Ireland
Salary: No information
Job Type: Contract
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The company are a global medical device company specialising in the manufacture of a number of devices in endoscopy, urology and Peripheral areas.

Role: Regulatory Affairs Specialist

Location: Limerick

Contract: An initial 6 month hourly rate contract

Your role as a Regulatory Specialist will be to assist in the running of the Regulatory Affairs function. You will also perform activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets,and provide regulatory affairs support for other functional areas.

Responsibilities:

  • Plans and prepares regulatory submissions for specific target markets on new products, product changes and re-registrations as needed.
  • Reviews submissions to ensure compliance to the regulations in particular jurisdictions.
  • Develops global regulatory strategies for the company's high-risk medical devices in collaboration with other regulatory affairs and clinical personnel.
  • Maintains an excellent understanding of global medical device regulations and a thorough understanding of the products assigned to the team.
  • Communicates updates to regulatory requirements and the status of projects to RA Management and other stakeholders as required.

Requirements:

  • Third level degree in Science / Quality disciplines
  • 5+ years experience as a Regulatory Specialist within the medical device industry.
  • Knowledge of medical device quality standards/practises or similar regulated industry.
  • Good communication and inter-personal skills.
  • Proven problem-solving and organisational skills.
  • Approved External Auditor.

This is an excellent opportunity to work within a global medical device company, alongside and enthusiastic and driven regulatory team.

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

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