Auditor & Product Expert - Berlin, Deutschland - BioTalent
Beschreibung
I am working with a international governing body dedicated to the regulation of Medical Device products across Europe.You will play a crucial role overseeing, auditing and regulating new and existing Medical Devices across Europe, being on the edge of innovation.
Please note this is afull time position, we offer both
hybrid and remote work with the opportunities.
About this role
In this position you will combine technical know-how with project management, organizational skills and coordination skills. You have the opportunity to work closely with medical device manufacturers, regulatory authorities, specialists and auditors within the organization.
Your main tasks include:
- Conducting onsite audits for active medical device manufacturers and their suppliers, aligning with EU Medical Device Regulations (MDR) and other QMS certification standards like ISO 13485 and MDSAP.
- Compiling comprehensive final reports and documentation.
- Engaging in projects related to global regulatory affairs.
- Providing diligent customer support on a national and international scale.
- Guaranteeing the punctual execution of project tasks.
- 4+ Years' General Experience
- 2+ Years' of Device Product Knowledge
- Life Sciences Related Education
- Fluent German (B1+)
Salary: 50,135.88€ - 87,555.09€ per year
Work Location:
Hybrid remote in 13127 Berlin
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