Medical Device Change Control Expert

RM IT Services GmbH

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Job ID :


Company Type :

Staffing Firms

Industry :


Education Level :

Bachelor of Business Administration,Bsc,Master of Science

Address 1 :

Western Europe,--Basel,Basel,

Key Skills :

Medical Devices, GMP, Validation, Moulder, Validation, DHF, Design History Files, Human factor,

Salary :


Date Posted :

16 Jul, 2018

Company Name :

RM IT Services GmbH

Location1 :


Job Category :

Pharma Manufacturing Jobs

Experience :


Job Type:


Travel Amount:

upto 15%


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 Name:

RM IT Services GmbH


Hackescher Markt 2-3,


Staffing Firms







100 - 499


Pharmaceutical Recruitment

Phone No. :


Professional Resources, Professional Services Since its establishment in 1998, the RM Group has developed to become one of the leading companies in the field of IT Resources Management in Switzerland. As a specialised recruitment agency, we find highly qualified experts for your projects. This is the basic requisite for the targeted development of IT strategies and for the practical implementation of IT projects. The RM Group is among the few significant Swiss recruitment agencies which fulfills all requirements related to compliance and quality assurance per ISO 9001, ISO 14001, GoodPriv@cy® and EcoVadis certification.

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