Regulatory Expert in Medical Device Compliance

3 days ago

Cork, Cork, Ireland beBeeRegulatory Full time €80,000 - €95,000

Job Summary:

We are seeking a highly skilled Regulatory Associate to join our team. As a key member of our organization, you will be responsible for ensuring compliance with regulatory requirements and standards in the medical device industry.

About Us:

We are an innovative company disrupting paediatric ENT care with a streamlined, in-office ear-tube insertion device. We have scaled from Irish clinical success to U.S. regulatory approval and global roll-out under a multinational company. With a strong IP portfolio, seasoned leadership, and growing market presence, we're well-positioned to change the standard of care in paediatric ear surgery.

Key Responsibilities:
  • Support day-to-day regulatory activities and handle multiple projects related to regulatory compliance enhancements.
  • Assist in implementing MDSAP within the organization.
  • Support the team in obtaining/retaining country-specific regulatory registrations globally.
  • Work with the commercial team/distributors to ensure country-specific registration activities are understood and addressed.
  • Collaborate with interdisciplinary team members to ensure the effectiveness of the quality management system (QMS) to regulations.
  • Work closely with QA for internal and external audits, including notified body audits as required.
  • Support the wider team in ensuring product manufacture and testing meets CE mark and FDA submission requirements.
  • Partner with suppliers to ensure products' process validations and risk management files meet regulatory submission standards.
  • Provide strategic regulatory insight to team members on product development plans.
  • Maintain post-market surveillance activities, including logging customer complaints and adverse events, coordinating investigations, and addressing initiatives to test, change, and improve products as needed.
  • Monitor global regulatory trends and advise colleagues and partners to ensure compliance.
  • Evaluate manufacturing and labeling changes, and promotional materials for regulatory impact and compliance.
  • Maintain awareness of global regulatory legislation and assess its impact on business and product development programs.
  • Keep abreast of changes in domestic and international regulations and guidelines, advising key staff on compliance/non-compliance with current international regulations.
Requirements:
  • 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 desirable.
  • Thorough understanding and knowledge of ISO 13485, ISO 14971, EU MDR, UK MDR, MDSAP, US 21 CFR 820, and supporting standards.
  • Proven track record of successfully managing projects to deadlines.
  • Experience working directly with regulatory agencies.
  • Strong ability to manage critical projects as part of an interdisciplinary team.
  • Excellent problem-solving and communication skills.
  • Self-motivated, highly organized, and detail-oriented individual with excellent oral and written communication skills.
  • Able to work as part of a cross-functional team and thrive in a fast-paced environment.

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