Senior Regulatory Compliance Manager

2 weeks ago

Galway, Galway, Ireland beBeeRegulatory Full time €90,000 - €125,000
Job Title: Principal Regulatory Affairs Specialist

This is a senior-level role within our regulatory affairs team, responsible for providing expert guidance and support to ensure compliance with regulatory requirements.

Responsibilities:
  • Develop and maintain positive relationships with device reviewers through oral and written communications regarding pre-submissions strategy/regulatory pathway development testing requirements, clarification and follow-up of submissions under review.
  • Assist with departmental policy and procedure implementation.
  • Assist with Regulatory Affairs training to cross functional groups.
  • Generate and implement regulatory strategies for new and modified medical devices.
  • Act as a core member on manufacturing and development teams, providing Regulatory Affairs feedback and guidance throughout the product development cycle.
  • Prepare and submit regulatory applications, as well as internal regulatory file documentation.
  • Review and update EU Regulatory Documentation including Technical Documentation and Post Market Surveillance deliverables such as SSCPs.
  • Prepare FDA regulatory files such as pre-market approval (PMA's), supplements and amendments, 30-day notices, annual reports and 510ks.
  • Review device labeling and advertising materials for compliance with global submissions and applicable regulations; analyze and recommend appropriate changes.
  • Interface with manufacturing, engineering, R&D and quality representatives to provide consultation on the impact of proposed changes to product, processes and the quality system.
  • Review and sign-off on product and manufacturing changes for compliance with applicable regulations.
Requirements:
  • Level 8 Bachelor's Degree in STEM (regulatory affairs or relevant discipline)
  • Minimum of 7 years experience in Regulatory Affairs or a related discipline (e.g. Quality, R&D, Post Market) within the medical device industry
  • Demonstrated proficiency with relevant US/EU regulatory requirements for medical devices including Quality Systems standards
  • Prior experience with a variety of regulatory submissions for US and EU MDR
  • Adaptable and able to work independently with minimal supervision in a fast-changing environment
  • Demonstrated leadership, strategic thinking, project planning, and project management skills
  • Excellent oral/written communicator with ability to articulate ideas, transfer knowledge efficiently and effectively, influence and engage colleagues
  • Experience working in complex matrixed organizational structures with demonstrated capability to collaborate and influence across such an organization
  • Ability to effectively lead multiple regulatory projects and priorities
  • Experience working directly with FDA, Notified Bodies, or other regulatory agencies
About Us:

We are a leading medical device company committed to advancing science for life. Our mission is to transform lives through innovative medical solutions that improve patient outcomes, create value for our customers, and support our employees and the communities we serve.

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