Job Description :
- Support device regulatory filings for US FDA, EU (MDD/MDR), and Canada regulatory requirements.
- Works in close collaboration with internal stakeholders and supports multiple projects.
- Ensures compliance with global regulatory requirements and adherence to internal policies and processes.
- Support for responds to regulatory requests from across the organization in a timely manner.
- Partners with internal stakeholders (e.g., regions) to align on regulatory strategy in order to achieve business objectives.
- Support development of training programs for internal stakeholders, as needed.
- Support development of documents that are clear, concise, and complete to facilitate reviews/approvals.
- Perform Regular communication (quarterly) to key Global Regulatory Affair on projects Back up Single Point of Contact at site level for all regulatory communication and planning Attend bi-weekly meeting, monthly governance meeting and project specific meeting based on request Drive request for country registrations Drive, track and report on global registrations on monthly basis
- Ensure relevant regulatory tracker is updated Maintain database and repository of license and registration document
Skill & competencies :
- Have understanding of quality/regulatory affairs as it applies throughout the product lifecycle, preferably US FDA , EU MDD / MDR and Canada regulatory requirement
- Knowledge on general manufacturing processes (i.e GMP)
- Problem solving skill
- Communication skill on complex regulatory topics
- Good report writing skill
Educational Background :
Minimum Bachelor degree in science major (e.g. pharmacy, chemistry, physics) or in engineering major (e.g. Industrial , Electrical, Machine)
Other major would be considered as well
Experiences :
Minimum 1 years relevant experience in regulatory area or minimum 3 years in quality assurance / compliance function
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