Medical Device Technical Expert in Risk Management 

RM IT Services GmbH

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Job ID :


Company Type :

Staffing Firms

Industry :


Education Level :


Address 1 :

Western Europe,--Basel,Basel,

Key Skills :

Medical Device, Technical Expert, Risk Management

Salary :


Date Posted :

04 Jun, 2018

Company Name :

RM IT Services GmbH

Location1 :


Job Category :

Medical Jobs

Experience :


Job Type:


Travel Amount:



Medical Device Technical Expert in Risk Management wanted for our Basel based client in the pharmaceutical sector.

Your experience/skills:

* 5+ years' experience in device development of parenteral delivery systems, such as drug/device combination products and DHF documentation
* Excellent technical writing skills coupled with proficiency in Product Design and Design for Manufacturing
* Good understanding of medical device regulations like FDA 21CFR 820 and EU Medical Device Directive as well as combination products
* Good technical knowledge of primary containers and auto-injector development
* General understanding of Human Factors Engineering, Risk, clinical trial processes and requirements of pharmaceutical development
* Languages: fluent English both written and spoken

Your tasks:

* Leading specific risk management activities within projects and ensuring timely completion and quality of assigned risk management files
* Ensuring compliance with ISO 14971 in all development projects assigned as well as with regulatory and normative guidelines focusing on medical device risk management
* Conducting and providing guidance on the use of risk analysis for Use, Products, Components and Processes
* Guiding internal and external functions on creating, reviewing and approving medical device Risk Management Files
* Applying FDA CFR 820, ISO13485, and ISO 14971 Risk Management in assigned projects and author the documentation in the medical device risk management file
* Supporting DRA to prepare Medical Device/Combination Product pre-registration documents and answer health authority questions

Start: ASAP
Duration: 6MM+
Location: Basel, Switzerland
Ref.Nr.: BH12955

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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