Regulatory Affairs Manager
Salary/Rate:60,000EUR - 70,000EUR
Job type:Perm
Town/City:Tuttlingen
Country:Germany
Business Sectors:Regulatory Affairs, Quality
Job ref:25105
Post Date:17. 04. 2024
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About the Role
Regulatory Affairs Officer
Overview
Are you looking for a new challenge in regulatory affairs?
I am currently supporting a client who specializes in sleep diagnostics in southern Germany in hiring an expert in EU MDR, approval processes, IEC 60601, IEC 62304 and ISO 14971.
This is a hybrid working position where you can work 2/3 days from home.
Tasks
Your profile
Please apply with your CV or contact May-Lynn Capocciama-Knecht for further details on this opportunity and additional vacancies in R&D, Regulatory Affairs and Quality Management.
may-lynn.ck@adaptivelifescience.com
+49 30 1663 7750
#LI-MC2
Overview
Are you looking for a new challenge in regulatory affairs?
I am currently supporting a client who specializes in sleep diagnostics in southern Germany in hiring an expert in EU MDR, approval processes, IEC 60601, IEC 62304 and ISO 14971.
This is a hybrid working position where you can work 2/3 days from home.
Tasks
- Implementation and maintenance of regulatory approval of medical devices in accordance with EU MDR
- Assisting in the compilation of documentation and supporting in the creation and maintenance of risk management files in accordance with ISO 14971 and usability files in accordance with IEC 62366-1
- Support international distributors in the approval process of the medical devices
- PMS activities such as PMS files and vigilance investigations
Your profile
- Experience in areas such as regulatory affairs or technical documentation in the MedTech or medical device industry
- Solid foundational knowledge of relevant regulatory and normative requirements (MDD, MDR, ISO 13485 etc.)
- IT Skills such as MS Office
- Good communication and organizational skills as well as independence and reliability
- Fluency in English and German
Please apply with your CV or contact May-Lynn Capocciama-Knecht for further details on this opportunity and additional vacancies in R&D, Regulatory Affairs and Quality Management.
may-lynn.ck@adaptivelifescience.com
+49 30 1663 7750
#LI-MC2