Regulatory Affairs and Quality Lead
1 month ago
Job Title: Regulatory Affairs and Quality Lead
Job Summary:
The Regulatory Affairs and Quality Lead for Region Europe is responsible for overseeing and managing functions that support departmental initiatives and directives. This role involves setting priorities, monitoring, and reporting on budget, planning, logistics, and acting as a regional coordinator for regulatory submissions and strategies.
Key Responsibilities:
- Support, create and maintain the Regional Submission Process(s) and Regulatory Roadmap for European region.
- Inform and support local organizations regarding changes in legislation, providing interpretation and strategic advice.
- Be Elekta's representative in the region in interactions with international bodies in the field of regulatory submissions.
- Support locally appointed regulatory and quality staff in their interactions with national authorities and in preparations of submissions and compliance data.
Requirements:
- More than 5+ years of experience working with regulatory affairs in European region.
- Knowledge and proven track record in Regulatory Affairs for Medical Devices in European region.
- Knowledge of the European Directive for Medical Devices & experience of ISO 13485 preferred.
- Degree equivalent in an engineering related subject or a formal engineering apprenticeship with demonstrated experience in a similar role.
Benefits:
- Up to 25 paid vacation days (plus bank holidays)
- Holiday Purchase Scheme
- Private Medical Insurance
- Attractive Employer Pension Contribution Package
- Hybrid work option (you are required to work on location at least 3 days a week)
- Cycle to work scheme
- Life Assurance
- Onsite subsidized restaurant
- Love electric (Electric vehicle salary sacrifice scheme)
Sweden:
- 30 paid vacation days/year, additional 4 Elekta days off/year (plus bank holidays)
- Attractive defined contribution pension scheme
- Private Medical Insurance
- Lunch Benefit
- Contribution to wellness activities
- Hybrid work option (you are required to work on location at least 3 days/week)
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