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Senior Regulatory Affairs Specialist

Location: Sligo, Republic of Ireland Salary:
Sector: Pharma & Biotech, Medical Devices, Quality Assurance (QA), Operations, 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 are a globally recognised medical device company, specialising in the manufacture of wound care products and therapies. The company is a family owned company, ensuring it is a great place to work, with exposure to cross functional teams.

Your role as a Regulatory Affairs Specialist will be to aid in the development of regulatory strategies, perform activities associates with obtaining and maintaining regulatory approval in target markets.

Role: Regulatory Affairs Specialist

Location: Sligo

Contract: An initial 6 month hourly rate contract

Responsibilities:

  • Maintain an excellent understanding of global medical device regulations for specific areas in accordance with ISO13485:2016 standards.
  • Ensure a thorough understanding of products as they are assigned.
  • Plan and prepare regulatory submissions for specific target markets for new products, product changes and re registrations as required.
  • Provide support to currently marketed products as needed including input on change requests etc.
  • Maintain and organise appropriate regulatory records to demonstrate compliance with applicable regulations including ISO13485:2016.
  • Create technical file submissions to collate information for regulatory submissions.
  • Obtain information, create reports, develop summary reports to various countries.
  • Change controls for regulatory requirements.

Requirements:

  • 3 - 5 years experience within a highly regulated environments.
  • Experience in Regulatory Submissions and CE marking is essential.
  • Excellent organisational skills.
  • Ability to work as an individual, as well as part of a team.
  • Experience within the medical device industry is desirable.
  • Degree in Science / Engineering discipline.

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

This is an excellent opportunity to work as part of a global medical device company, alongside an innovative, and enthusiastic Regulatory team.

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