Senior Regulatory Affairs Manager

1 week ago

Dublin, Dublin City, Ireland beBeeRegulatory Full time €98,765 - €123,456

Are you a strategic thinker with expertise in Quality Assurance and Regulatory Affairs?

About the Role
  • We are seeking a skilled professional to lead our QA/RA strategy, ensuring alignment with business goals and regulatory requirements.
  • The ideal candidate will oversee regulatory submissions and communications with global regulatory bodies, including the FDA, EMA, and Notified Bodies.
  • They will ensure compliance with EU MDR, FDA 21 CFR Part 820, and other applicable regulations.
Key Responsibilities
  1. Develop and implement a comprehensive QA/RA strategy, aligning with business objectives and regulatory standards.
  2. Manage regulatory submissions, including documentation and communication with global regulatory agencies.
  3. Maintain and improve our ISO 13485 certified Quality Management System.
  4. Lead internal and external audits, CAPAs, and risk management activities.
  5. Collaborate with R&D, Clinical, and Operations teams to ensure regulatory and quality requirements are met throughout the product lifecycle.
  6. Stay up-to-date with changing global regulations and standards, making proactive updates to internal processes as needed.
What We Offer
  • A dynamic work environment with opportunities for growth and development.
  • A competitive compensation package, commensurate with experience.
  • A collaborative team atmosphere with a focus on continuous improvement.

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