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Regulatory Affairs Specialist

The company is a global leader within the medical device market. Their products focus on the screening and detection of medical allignments in newborn care and sleep disorders.

Role: Regulatory Affairs Specialist

Location: Galway

Contract: An initial 6 month hourly rate contract

Your role as a Regulatory Affairs Specialist will be to have a broad understanding of international regulatory requirements to support proper design and development of the medical devices. You will work alongside the product development teams to ensure that the products meet regulatory compliance standards for medical devices on site.

Responsibilities:

  • Be responsible for maintaining product registrations in all international markets.
  • Be up-to-date and follow all Quality System procedures related to this role.
  • Plan, execute, and maintain medical device product registrations and clearances in all international markets.
  • Participate in MDD/MDR, MDSAP, and FDA audits as required.
  • Be involved in internal audits.
  • Assess regulatory impact for new products and/or modifications to existing products.

Requirements:

  • Bachelor's Degree in Science or Engineering discipline.
  • 2+ years' experience within the medical device industry.
  • Ability to effectively present information.
  • Working knowledge of FDA, Health Canada, and EU medical device regulations is required.

This is an excellent opportunity for an experienced Regulatory Affairs Specialist to join an innovative Regulatory team, within a global medical device company.

No CV ready? Not sure yet? Feel free to contact me for more 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