Lead Regulatory Specialist

1 week ago

Galway, Galway, Ireland beBeeRegulatoryAffairs Full time €80,000 - €100,000
Job Description

We are seeking a seasoned Regulatory Affairs professional to join our team as Principal Regulatory Affairs Specialist. In this role, you will be responsible for supporting the product development process, submissions, and regulatory compliance.

  • Act as a key representative, developing and maintaining 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.
  • Collaborate with departmental stakeholders to implement policies and procedures.
  • Provide Regulatory Affairs training to cross-functional groups.
  • Develop and implement regulatory strategies for new and modified medical devices.
  • Partner with manufacturing and development teams to provide 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 representatives from manufacturing, engineering, R&D, and quality 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:
  • Bachelor's degree in a relevant STEM field or equivalent experience.
  • Minimum of 7 years experience in Regulatory Affairs or a related discipline within the medical device industry.
  • Proven proficiency with relevant US/EU regulatory requirements for medical devices including Quality Systems standards.
  • Experience with a variety of regulatory submissions for US and EU MDR.
  • Ability to work independently with minimal supervision in a fast-changing environment.
  • Leadership, strategic thinking, project planning, and project management skills.
  • Excellent communication and interpersonal skills with ability to articulate ideas, transfer knowledge efficiently, 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 regulatory agencies.
  • Experience with data analytics or AI tools to identify and drive operational efficiencies is a plus.

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