Regulatory/Quality Assurance Specialist 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.As a Regulatory/Quality Assurance Specialist you will be trusted to work on implementing and maintaining the regulatory strategy at Alcon Benelux. In this role, a typical day will include:
1. Collaborating with internal stakeholders to solve regulatory and quality challenges.
2. Acting as Deputy Management Representative for Alcon Benelux in accordance with ISO/EN ISO 13485 and applicable Quality System standards.
3. Leading multiple projects and providing support for non-project related "regulatory excellence" activities.
4. Ensuring compliance with global regulatory requirements and adherence to internal policies and processes.
5. Responding to regulatory requests from across the organization in a timely manner.
6. Support New product launches according to plan, including labeling update review
WHAT YOU’LL BRING TO ALCON:
7. Education: Master/bachelor's degree or equivalent experience.
8. Experience: Proven experience in regulatory and/or Quality environment in medical devices or pharmaceutical business.
9. Languages: Fluency in English and Dutch; French is an asset
10. Technical Skills: Strong writing skills for high-quality regulatory submission documents, ability to manage issues proactively, resolve conflicts, and mitigate risks.
11. Behaviors: Demonstrated ability to coordinate and work effectively with multiple stakeholders, good organizational and time management skills, commitment to driving efficiency while maintaining quality.
HOW YOU CAN THRIVE AT ALCON:
12. Autonomy: Opportunity to lead projects and initiatives independently.
13. Challenging Work: Engage in complex regulatory and quality assurance tasks that drive superior results.
14. Team Environment: Collaborate with diverse, talented colleagues in a supportive and inclusive culture.