Life Science Compliance Specialist

1 week ago

Cork, Cork, Ireland beBeeRegulatory Full time €60,000 - €80,000
Regulatory Affairs Professional

We are seeking a skilled Regulatory Affairs Associate to support day-to-day regulatory activities and handle multiple projects related to regulatory compliance enhancements.

This exciting role offers the opportunity to develop your experience and career in a life-science company, working closely with interdisciplinary team members to ensure the effectiveness of the quality management system (QMS) to regulations.

  • Support day-to-day regulatory activities, including handling multiple projects related to regulatory compliance enhancements.
  • Implement MDSAP within the organisation, ensuring compliance with EU MDR, UK MDR, US 21 CFR 820 and supporting standards.
  • Obtain and retain country-specific regulatory registrations on a global basis, working closely with the commercial team and distributors.
  • Coordinate investigations between complainants and contract manufacturing sites, addressing initiatives to test, change and improve products as required.

The ideal candidate will have a strong understanding and knowledge of ISO 13485, ISO 14971, EU MDR, UK MDR, MDSAP, US 21 CFR 820 and supporting standards. They will also have proven track record with the ability to successfully manage projects to deadlines and experience working directly with regulatory agencies.

Required skills and qualifications include a bachelor's degree in engineering or science with a minimum of 3 years of regulatory experience in the medical device industry. Regulatory certifications in EU MDR and US FDA are desirable.

This role is ideal for those looking to develop their career in regulatory affairs and make a meaningful contribution to a life-science company. If you have a passion for regulatory compliance and a drive to succeed, we encourage you to apply.

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