Sr. Associate, Regulatory Affairs Strategy

· Support the development and execution of regulatory strategies and plans for new and marketed products, ensuring timely submissions, approvals, and lifecycle compliance in collaboration with Global Regulatory Affairs and cross-functional stakeholders.

· Prepare and support submission of regulatory dossiers (as required) tailored to local requirements to facilitate efficient health authority review and approval.

· Maintain all product and establishment licenses (e.g., marketing authorizations, import licenses) to ensure uninterrupted business continuity.

· Maintain accurate regulatory records and databases (e.g., Veeva RIM), ensuring all product information and submission statuses are current and audit-ready.

· Monitor regulatory changes, conduct regulatory impact assessments and gap assessments as needed, and support updates to internal policies, procedures, and documentation.

· Engage with internal stakeholders and support interactions with Health Authorities to enable effective regulatory execution and alignment with business objectives.

· Perform review and approval (as applicable) of local labeling, advertising, and promotional materials in compliance with applicable regulations and company standards.

· Provide regulatory support for market actions (e.g., FSCAs, recalls) and related health authority communications.

· Support initiatives to drive performance improvements and contribute to achieving performance targets and operational excellence.

· Deliver timely responses to regulatory queries from stakeholders across the organization

· Perform additional duties as required by the regional or affiliate QRA function.

· BSc Degree in a Scientific or Engineering discipline or related field

· Proven experience (at least 2 years) in Regulatory Affairs function in the medical device or pharmaceutical industry, including comprehensive knowledge of ISO13485 and/or similar

· Very good command of English (written and spoken), Nordic language is considered a strong advantage

· Experience working in an international environment

· Excellent communication and interpersonal skills

· Strong stakeholder management skills, with the ability to build effective relationships across different functions and levels of the organization

• Collaborate with teammates to share standard processes and learnings as work evolves!
• Attractive benefits package (private medical care, group insurance, lunch card, transportation allowance, pension plan, Multisport/cultural card, Alcon products for you and your significant other)
• Employment contract, full‑time position
• Hybrid work (3/2/weekly)
• Modern office with many facilities inside located at NewCity building, 15 Marynarska Street, Warsaw

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