Medical Device Compliance Specialist

2 weeks ago

Cork, Cork, Ireland beBeeRegulatory Full time €60,000 - €80,000

Job Title: Senior Regulatory Affairs

Location: Cork

The organization has recently undergone an acquisition and developed a groundbreaking single-use medical device that addresses pain points of the current treatment of surgical tympanostomy, a procedure that drains excess fluid built up in the ear.

Responsibilities:
  • Develop and execute regulatory strategies for product registration, approval, and compliance.
  • Manage day-to-day regulatory activities and handle multiple projects related to regulatory compliance enhancements.
  • Management of regulatory submissions, including preparation, maintenance, review, and submission of regulatory documents and applications to health authorities.
  • Support the team to obtain/retain country-specific regulatory registrations on a global basis.
  • Manage the implementation of MDSAP within the organization.
  • Monitor and ensure compliance with national and international regulatory requirements and quality standards.
  • Identify and assess potential regulatory risks and propose/implement effective mitigation strategies.
  • Work closely with QA, R&D, Operations, Clinical Affairs, and other departments to integrate regulatory requirements into QMS and product development processes.

Key Skills:

  • Proven track record with ability to successfully manage projects to deadlines.
  • Experience working directly with regulatory agencies.
  • Strong ability to manage critical projects as part of an interdisciplinary team.
  • Bachelor's degree in Engineering or Science with a minimum of 6 years of regulatory experience in the medical device industry.
  • Regulatory certifications in EU MDR and US FDA desirable.

We offer our employees competitive compensation and benefits packages, including comprehensive health insurance, a 401(k) plan, and opportunities for professional growth and development.

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