Regulatory Affairs Specialist (m/f/d)
at
HumanOptics Holding AG
Berlin, Berlin, Germany
-
Full Time
Start Date
Immediate
Expiry Date
10 Nov, 26
Salary
50000.0
Posted On
07 Oct, 26
Experience
0 year(s) or above
Remote Job
Yes
Telecommute
Yes
Sponsor Visa
No
Skills
Industry
Pharmaceutical Manufacturing
Description
Approval and registration of medical devices in national and international markets
Preparation of documents for authentication and legalization
Support in maintaining and collaborating on the creation of technical product documentation, including risk management files and regulatory documents within the framework of international regulatory strategies.
Project support for the implementation of the requirements of the new EU Medical Device Regulation and support in maintaining the corresponding approvals.
Internal contact person and contact person for business partners regarding regulatory issues
Regulatory assessment of product and document changes relevant to approval
Support in revising and creating RA-relevant QM documents
Support in ensuring compliance with all guidelines, laws, standards and country-specific requirements.
Researching guidelines and laws
Close internal communication and coordination with other departments
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