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Medical Device Change Control Expert, Basel



Basel, Switzerland 

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CHF€0.00 - CHF €0.00

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Job Description:

Medical Device Change Control Expert wanted for our Basel based client in the pharmaceutical sector.

Your experience/skills:

* Master degree in Science or Engineering with 5+ years’ experience in related field
* Working experience in managing medical device and combination product Change Controls as well as pre-filled-syringe device development, from early phase activities up to commercialization and production scale-up
* Familiarity with medical device quality assurance and medical device regulations, ISO13485
* Understanding of DHF compilation, including Design Control process and other applicable regulatory, QA and GMP aspects
* Basic understanding of pharmaceutical development, of Human Factors Engineering and Risk management as well as of manufacturing
* Languages: fluent English both written and spoken

Your tasks:

* Managing change control activities within the development and life cycle management of parenteral delivery systems, such as drug or device combination products and medical devices
* Rolling out of new change control process including training of personnel on process and systems
* Collaborating with team members across sites to ensure quality documentation meeting all regulatory requirements
* Working with a team to understand and remove roadblocks in completing changes
* Reporting KPIs to ensure timelines of change control actions

Start: ASAP
Duration: 06MM+
Location: Basel, Switzerland
Ref.Nr.: BH13192

Does this sound like an interesting and challenging opportunity to you? Then take the next step by sending us your CV as a Word document and a contact telephone number.

Due to work permit restrictions we can unfortunately only consider applications from EU or Swiss citizens as well as current work-permit holders for Switzerland.

Going the extra mile…

New to Switzerland? In case of successful placement, we support you with:

* All administrative questions
* Finding an apartment
* Health – and social insurance
* Work permit and much more
Company Info
RM IT Services GmbH
Hackescher Markt 2-3
Berlin, Berlin, Germany
Web Site: www.rmgroup.ch
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