Senior Regulatory Affairs Specialist
You will provide leadership for the site for Regulatory Affairs for NPD projects and continue to do so as the company continue their strong growth.
- Define data and information required for regulatory approvals and guide conformance in product development, content labelling and promotional materials.
- Define best practice for regulatory affairs processes.
- Utilise your deep scientific and technical understanding of regulated products to provide strategic guidance for life cycle management and product development.
- Manage the transition to the new MDR requirements and ensure compliance to notified body requirements.
- Develop labelling specifications and approve ant proposed labelling and packaging.
- Provide regulatory support to project teams and provide support during internal and external audits. Similarly represent regulatory affairs on cross functional project teams.
- Must have a degree in science or engineering or a similar field with 5 years or more experience in the medical device industry and 2 or more in regulatory affairs.
- Should have prior experience in submissions, international registrations and dossiers and delivering upon the regulatory strategy.
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