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Regulatory Affairs Manager at PTW Freiburg GmbH

Berlin, Berlin, Germany -

Full Time

Start Date

Immediate

Expiry Date

30 Dec, 26

Salary

60000.0

Posted On

01 Oct, 26

Experience

3 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Industry

Hospitals & Health Systems

Description

Successfully completed technical or scientific studies – alternatively, a comparable qualification with relevant professional experience
Several years of experience in Regulatory Affairs in the medical technology sector
Sound knowledge of regulatory requirements (e.g. MPDG, MDR), as well as relevant standards such as ISO 13485, ISO 14971, IEC 60601-1/2, IEC 62304
Experience in creating technical documentation for international approvals
Project management experience
Good to very good German and English skills, both spoken and written.
Proficient use of MS Office, especially Word and Excel

Responsibilities

Successfully completed technical or scientific studies – alternatively, a comparable qualification with relevant professional experience
Several years of experience in Regulatory Affairs in the medical technology sector
Sound knowledge of regulatory requirements (e.g. MPDG, MDR), as well as relevant standards such as ISO 13485, ISO 14971, IEC 60601-1/2, IEC 62304
Experience in creating technical documentation for international approvals
Project management experience
Good to very good German and English skills, both spoken and written.
Proficient use of MS Office, especially Word and Excel