Senior Regulatory Compliance Manager

17 hours ago

Cork, Cork, Ireland beBeeRegulatory Full time €100,000 - €120,000
Regulatory Specialist Role

About the Job:

This position offers an exciting opportunity to be at the forefront of innovation and contribute significantly to our company's success. You will play a crucial role in ensuring our products and services comply with all relevant regulations and standards.

Key Responsibilities:

  • Develop and execute regulatory strategies for product registration, approval, and compliance.
  • Manage day-to-day regulatory activities, handle multiple projects related to regulatory compliance enhancements, and manage regulatory submissions.
  • Support the team to obtain / retain country-specific regulatory registrations on a global basis.
  • Implement MDSAP within the organization and ensure compliance with national and international regulatory requirements and quality standards.
  • Identify and assess potential regulatory risks and propose/implement effective mitigation strategies.
  • Collaborate with QA, R&D, Operations, Clinical Affairs, and other departments to integrate regulatory requirements into QMS and product development processes.
  • Stay current with changing regulations, guidelines, and industry trends.
  • Contribute to maintaining the highest level of quality within the organization by assessing overall risk profiles and creating programs/tools to mitigate potential risks.
  • Manage Post Market Surveillance, including customer complaints, adverse events, investigations, and initiatives to test, change, and improve products as required.

Requirements:

  • 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 are desirable.
  • Thorough understanding and knowledge of ISO 13485, ISO 14971, EU MDR, UK MDR, MDSAP, 21 CFR 820, and supporting standards.
  • Proven track record with the ability to successfully manage projects to deadlines.
  • Experience working directly with regulatory agencies is essential.
  • Strong ability to manage critical projects as part of an interdisciplinary team.

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