Regulatory Affairs Specialist

4 days ago

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

We are seeking an experienced Regulatory Affairs Specialist to join our team. As a key member of the Regulatory Affairs department, you will be responsible for ensuring compliance with regulatory requirements and guidelines.

Key Responsibilities:
  • Develop and maintain positive relationships with regulatory reviewers through effective oral and written communications.
  • Assist with the implementation of departmental policies and procedures.
  • Provide Regulatory Affairs training to cross-functional groups.
  • Generate and implement regulatory strategies for new and modified medical devices.
  • Collaborate with manufacturing and development teams to provide Regulatory Affairs feedback and guidance.
  • Prepare and submit regulatory applications, including internal regulatory file documentation.
  • Review and update EU regulatory documentation, including technical documentation and post-market surveillance deliverables.
  • Prepare FDA regulatory files, such as pre-market approvals, supplements, and amendments.
  • Review device labeling and advertising materials for compliance with global submissions and applicable regulations.
  • Interface with manufacturing, engineering, R&D, and quality representatives to provide consultation on proposed changes.
Requirements:
  • Bachelor's degree in a STEM field, such as regulatory affairs or a related discipline.
  • Minimum 7 years of experience in Regulatory Affairs or a related field within the medical device industry.
  • Demonstrated proficiency with relevant US/EU regulatory requirements for medical devices.
  • Prior experience with various 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 skills, including oral and written abilities.
  • Experience working in complex matrixed organizational structures.

This is an exciting opportunity to join our team and contribute to the success of our organization. If you have a passion for regulatory affairs and a desire to work in a dynamic environment, we encourage you to apply.

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