- 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.
- 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
- A competitive salary package with fixed salary, bonus, pension, and health insurance
- A flexible work environment with competent and committed colleagues. We enjoy working together in a good and respectful manner, and we celebrate our common successes.
- See your career like never before with focused growth and development opportunities.
Regulatory Affairs Manager - Cork, Ireland - IE13 Alcon Laboratories Company
Description
Regulatory Affairs Manager
At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you'll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon.
Alcon is the global leader in eye care, dedicated to helping people see brilliantly. With our 70-plus-year heritage, we are the largest eye-care device company in the world – with complementary businesses in Surgical and Vision Care. Being a truly global company, we work in over 70 countries and serve patients in more than 140 countries.
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:
What You Will Bring to Alcon:
How You Can Thrive At Alcon