Regulatory Affairs Manager

Regulatory Affairs Manager


Cork, Ireland

We are currently recruiting for a Regulatory Affairs Manager to join our team here in Cork. The successful candidate will Manage Regulatory Affairs and Regulatory Affairs Assessor team for the site. Act as Management Rep. Responsible for all regulatory strategy, submissions, and change management at the site ensuring compliance with GMP, ISO and applicable Alcon regulatory requirements.

In this role, a typical day would include:

  • Manage and/or prepare device regulatory filings with a thorough understanding of the US FDA, Canada, and EU (MDD/MDR) regulatory requirements;
  • Review and assess facility change controls for potential impact on current medical device regulatory filings in US (Class II and III), Canada (Class III), EU (Class IIa and IIb), and Rest of World;
  • Provides high quality regulatory support for assigned products/projects;
  • Coordination and establishment of global product and facility registrations as needed;
  • Leads close collaboration with internal stakeholders and supports multiple projects;
  • Support regulatory inspections including facility preparedness;
  • Partners with internal and external stakeholders (e.g., regions, Health authorities) to align on an optimized regulatory strategy in order to achieve business objectives;
  • Manage and maintain a suitably resourced group with appropriately qualified personnel within budget;
  • Ensures awareness of and compliance with global regulatory requirements and adherence to internal policies and processes;
  • Ensure continual Quality System compliance by adherence to established documentation compliance to FDA QSRs, ISO 13485, and evolving Alcon QS requirements;
  • Participate in Business Continuity exercises and ensure templates are completed for all critical areas of the regulatory department;
  • Identifies and executes non-project related "regulatory excellence" activities;
  • In a timely manner, provides solutions to a range of regulatory issues and has the freedom to act independently to execute;
  • Drives superior results by taking initiative, planning and implementing projects, setting priorities and holding self and others accountable to meet commitments.

What You Will Bring to Alcon:

  • Minimum 5 years experience in a similar role in the Medical Device Industry;
  • 3 years demonstrated leadership experience in projects or people;
  • Bachelors in a relevant field;
  • Experience in a regulatory role for Class III medical devices;
  • Optical experience is a plus.

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