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Medical Device Process Specialist
2 weeks ago
Ambu A/S is a globally operating company that develops and manufactures single-use medical devices.
We are looking for a Medical Device Process Specialist to join our team in Copenhagen, Denmark.
About the role:
- Lead the development, implementation, and maintenance of R&D design-control processes in compliance with regulatory requirements (FDA, ISO, etc.)
- Identify opportunities for process improvements and lead initiatives to enhance efficiency, effectiveness, and compliance within the design control and process framework
- Support the development projects in following the processes and support preparation of design control documentation in innovation projects
- Prepare and support internal and external audits related to R&D processes. Implement corrective and preventive actions as needed
- Cross-functional Collaboration: Work closely with stakeholders within R&D, Quality Assurance, Regulatory Affairs, and other relevant departments to align on best practices and implement regulatory requirements throughout the product lifecycle
About you:
- Experience with creation and/or implementation of procedures
- Experience with training, facilitating and coaching users of the procedures
- Have a can-do mindset, and thrive in collaborating across teams, functions and cultures
- A relevant educational background, e.g. Science, Engineering and/or tech.
- Experience with participation in inspections and/or audits would be a plus
- Experience with design control in a Medical Device Company is a huge plus
