Regulatory Affairs Manager
at
Thermo Fisher Scientific
Berlin, Berlin, Germany
-
Full Time
Start Date
Immediate
Expiry Date
21 Dec, 26
Salary
45000.0
Posted On
22 Sep, 26
Experience
2 year(s) or above
Remote Job
Yes
Telecommute
Yes
Sponsor Visa
No
Skills
Industry
Pharmaceutical Manufacturing
Description
You monitor national and international regulatory requirements (e.g., IVDR, FDA and relevant standards), assess their impact and derive appropriate measures.
You ensure that our products always comply with regulatory requirements and environmental regulations such as RoHS, REACH and WEEE.
You will actively contribute to the further development and harmonization of our global regulatory affairs processes and introduce optimization potential.
As a competent contact person, you will support interdisciplinary teams from research & development, quality management and production with regulatory issues.
You coordinate and support communication with authorities and notified bodies and assist with issues related to post-market surveillance and vigilance.
You will assist in the planning, preparation and execution of internal and external audits and contribute to the continuous improvement of our regulatory management system.
Responsibilities
You monitor national and international regulatory requirements (e.g., IVDR, FDA and relevant standards), assess their impact and derive appropriate measures.
You ensure that our products always comply with regulatory requirements and environmental regulations such as RoHS, REACH and WEEE.
You will actively contribute to the further development and harmonization of our global regulatory affairs processes and introduce optimization potential.
As a competent contact person, you will support interdisciplinary teams from research & development, quality management and production with regulatory issues.
You coordinate and support communication with authorities and notified bodies and assist with issues related to post-market surveillance and vigilance.
You will assist in the planning, preparation and execution of internal and external audits and contribute to the continuous improvement of our regulatory management system.
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