Sr. Specialist Regulatory Affairs

☞ Alcon

View: 135

Update day: 17-11-2025

Location: Puurs Antwerp

Category: Legal / Contracts

Industry: Medical Equipment Manufacturing

Position: Entry level

Job type: Full-time

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Job content

The Sr. Regulatory Specialist is responsible for the implementation and maintenance of the defined regulatory strategy, under limited supervisionMajor Accountabilities
  • Manage and/or prepare device regulatory filings with a thorough understanding of the US FDA and EU (MDD/MDR) regulatory requirements.
  • Review and access process and/or design change controls for potential impact on current medical device regulatory filings.
  • Provides high quality regulatory support for assigned products/projects.
  • Works in close collaboration with internal stakeholders and supports multiple projects.
  • Provides support as needed for non-project related "regulatory excellence" activities.
  • Ensures compliance with global regulatory requirements and adherence to internal policies and processes.
  • Responds to regulatory requests from across the organization in a timely manner.
  • Provides high quality regulatory support for assigned products/projects.
  • Partners with internal stakeholders (e.g., regions) to align on regulatory strategy in order to achieve business objectives.
  • Develops training programs for internal stakeholders, as needed.
  • Develops documents that are clear, concise, and complete to facilitate reviews/approvals.
Requirements
  • Written and verbal English communication skills are required.
  • Bachelor Degree and at least 4 years of relevant experience OR Master Degree with 2 years related experience
  • Experience within Medical Devices industry preferred
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Deadline: 01-01-2026

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