Alcon seeks a Senior Associate for Regulatory Affairs Strategy in Fribourg, CH. The role focuses on ensuring product compliance, managing registrations, and supporting strategic regulatory decisions.
This position sits within Alcon's Quality & Regulatory Affairs team. The primary purpose is to guarantee that products meet global, local, and internal regulatory standards while maintaining active product registrations. The role also involves collaborating with internal teams and regulatory bodies to inform strategic choices and ensure ongoing compliance.
Responsibilities
- Develop and implement regulatory strategies for both new and existing products, ensuring timely submissions and lifecycle compliance.
- Prepare and submit regulatory dossiers adapted to local requirements to streamline health authority reviews.
- Keep all product and establishment licenses active to support continuous business operations.
- Manage regulatory records and databases, ensuring product data and submission statuses are up-to-date and ready for audits.
- Track regulatory updates, perform impact and gap assessments, and assist in revising internal policies and documentation.
- Collaborate with internal stakeholders and facilitate interactions with health authorities to align regulatory execution with business goals.
- Review and approve local labeling, advertising, and promotional materials to ensure compliance with regulations and company standards.
- Provide regulatory support for market actions and related communications with health authorities.
- Contribute to performance improvement initiatives and help achieve operational targets.
- Respond promptly to regulatory inquiries from across the organization.
Requirements
- Bachelor's degree in a scientific or engineering field or a related discipline.
- Minimum of two years of experience in Regulatory Affairs within the medical device or pharmaceutical sector.
- Strong understanding of ISO 13485 or equivalent standards.
Nice to have
What the company offers
- Opportunities for professional growth and development.
About the company
Alcon is dedicated to improving vision and helping people see clearly. The company promotes an inclusive environment that values employee contributions and supports career advancement. Alcon encourages fearless innovation, drives progress, and takes swift action to positively impact global eye health.
- Commitment to enhancing vision and supporting clear sight.
- Inclusive workplace culture that recognizes contributions and supports career growth.
- Culture of fearless innovation and swift action to improve global eye health.
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