Medical Device Project Leader

RM IT Services GmbH


Job ID :

13026


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bachelor of Business Administration


Address 1 :

Western Europe,--Basel,Basel,


Key Skills :

Medical Device Project Leader


Salary :

Negotiable


Date Posted :

24 Sep, 2018



Company Name :

RM IT Services GmbH


Location1 :

Basel




Job Category :

Pharma Distribution & Logistics Jobs


Experience :

Fresher


Job Type:

Contract


Travel Amount:

negotiable





Description

Medical Device Project Leader wanted for our Basel based client in the pharmaceutical sector.

Your experience/skills:

* University degree in Packaging Science/Engineering or Mechanical Engineering or University level Engineering education
* 7 + years' work experience in leading device development technical teams or in a similar area along with profound background in Project and Program Management
* Know-How of pharmaceutical development in general and Medical Device Regulations such as FDA 21CFR 820, FDA 21CFR Part 4, EU Medical Device Directive, EU Medical Device Regulation
* Competency in developing and writing of technical documentation, in drug/device combination products and medical devices as well as in Design Control process and other applicable regulatory, QA and GMP aspects
* Good command of managing external suppliers, Product Design or Design for Manufacture and of test and verification, including development of methods and equipment
* General understanding of Human Factors Engineering, clinical studies processes, risk management and requirements
* Languages: fluent English both written and spoken, German and French would be an advantage

Your tasks:

* Conducting the definition of product requirements for packaging, delivery systems and medical devices such as drug and device combination products
* Observing work progresses and supporting technical development including test and verification work as well as controlling the development and implementation of manufacturing processes
* Supplying primary packaging and device expertise in a broader cross-functional drug product development team as well as managing the collaboration with external development partners
* Supporting and coordinating the manufacturing of clinical material and the production scale up
* Providing support to cross functional project teams in the development, review and submission of regulatory dossiers along with monitoring Human Factors Engineering activities
* Managing and securing Risk management activities, design verification activities and technical documentations
* Maintaining high quality of Design History File and transferring it to production

Start: 10/2018
Duration: 06MM+
Location: Basel, Switzerland
Ref.Nr.: BH13522

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…


Company Name:

RM IT Services GmbH


Headquarters:

Hackescher Markt 2-3,


Sector:

Staffing Firms


Country:

Germany


Zipcode:

10178


Website:

www.rmgroup.ch


Employees:

100 - 499


Industry:

Pharmaceutical Recruitment


Phone No. :

+41583560693


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.

For more information,visit www.rmgroup.ch.

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