RegulatoryQuality Assurance Specialist
RegulatoryQuality Assurance Specialist
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Job Description
- Collaborating with internal stakeholders to solve regulatory and quality challenges.
- Acting as Deputy Management Representative for Alcon Benelux in accordance with ISO/EN ISO 13485 and applicable Quality System standards.
- Leading multiple projects and providing support for nonproject related regulatory excellence activities.
- Ensuring compliance with global regulatory requirements and adherence to internal policies and processes.
- Responding to regulatory requests from across the organization in a timely manner.
- Support New product launches according to plan including labeling update review
- Education: Master/bachelors degree or equivalent experience.
- Experience: Proven experience in regulatory and/or Quality environment in medical devices or pharmaceutical business.
- Languages:Fluency in English and Dutch; French is an asset
- Technical Skills:Strong writing skills for highquality regulatory submission documents ability to manage issues proactively resolve conflicts and mitigate risks.
- Behaviors:Demonstrated ability to coordinate and work effectively with multiple stakeholders good organizational and time management skills commitment to driving efficiency while maintaining quality.
- Autonomy:Opportunity to lead projects and initiatives independently.
- Challenging Work:Engage in complex regulatory and quality assurance tasks that drive superior results.
- Team Environment:Collaborate with diverse talented colleagues in a supportive and inclusive culture.
If you are currently an active employee/contingent worker at Alcon please click the appropriate link below to apply on the Internal Career site.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
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