Quality Assurance & Regulatory Affairs Specialist (with German)
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Job Location:
Monthly Salary:
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
If you want to:
- Work in a key role supporting Quality Assurance and Regulatory Affairs activities with external partners
- Influence how QMS audits documentation control and biocompatibility coordination are handled across Demant and 3rdparty partners
- Join an international organization with Scandinavian work culture based on openness trust and collaboration
We are waiting to hear from you!
We are looking for a Quality & Regulatory Affairs Specialist to support our quality and regulatory activities between Demant and our 3rdparty business partners.
Working with us you will receive:
- Fulltime employment in a stable international organization
- Learning & development opportunities tailored to your growth
- Hybrid work model with an office in Szczecin City Center
- Flexible working hours
- Benefits package (private medical care life insurance sports card etc.)
- Scandinavian work culture informal collaborative focused on equality and worklife balance
What tasks are waiting for you
- Support the 3rdparty business with QA and RArelated activities
- Maintain documentation to support audit activities between 3rdparty partners and Demant
- Maintain and update 3rdparty MDF documentation
- Support preparation of management review inputs
- Coordinate regulatory monitoring assessments and decisions between Demant and its partners
- Coordinate Biocompatibility activities with internal and external stakeholders
Apply today if you:
- have strong attention to detail and a structured approach to work
- understand quality standards and regulatory frameworks (ISO 13485 MDR 2017/745 MDSAP)
- communicate clearly and professionally
- can work effectively with crossfunctional teams
- have strong documentation management skills
- have good command of German and English
- have experience within the medical devices industry (preferred)
It would be nice if you:
- worked with QMS processes in a regulated environment
- have knowledge of regulatory requirements related to product submissions
If you have any questions contact the recruiter: Jakub ()
Furthermore we would like to inform you that the company has an internal reporting procedure which is available at:demantcompliance - Make a report ()
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Required Experience:
IC
Key Skills
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About Company
Leading in hearing healthcare Demant is the only company in the world that covers all areas of hearing healthcare, from hearing devices and hearing implants to diagnostic instruments and professional hearing care, and we harvest significant synergies from this unique position and exp ... View more
