Regulatory Affairs and Quality Lead
2 days ago
Elekta AB is seeking a highly skilled Regulatory Affairs and Quality Lead to oversee and manage functions that support departmental initiatives and directives in the European region.
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 the European region.
- Inform and support local organizations regarding changes in legislation, providing interpretation and strategic advice.
- Represent Elekta in international regulatory bodies and interactions with local organizations.
- 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 the European region.
- Knowledge and proven track record in Regulatory Affairs for Medical Devices in the European region.
- Knowledge of the European Directive for Medical Devices and experience of ISO 13485 would be preferred.
- Degree equivalent in an engineering-related subject or a formal engineering apprenticeship with demonstrated experience in a similar role.
Benefits:
- Competitive salary and benefits package.
- Opportunity to work with a leading company in the medical technology industry.
- Chance to develop your skills and expertise in regulatory affairs and quality management.
How to Apply:
Apply by submitting your application and resume in English via the "Apply" button. We look forward to hearing from you.
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