• Michael Page Oil & Gas
  • Michael Page Oil & Gas
  • Michael Page Oil & Gas
  • Michael Page Oil & Gas
  • Michael Page Oil & Gas
  • Michael Page Oil & Gas

European RA/QA Manager

Job Ref No: 
Location (Region): 
Western Europe,----Amsterdam
Phone Number: 
+31 20 5789962
Local Salary: 
Floor Dijkshoorn

As the European RA/QA Manager you will be responsible for all regulatory affairs and quality assurance related activities for the European region. We are exclusively searching for candidates with strong decision making and problem solving skills.

Job Description: 

In the responsible position as European RA/QA Manager you manage and organise all regulatory affairs and quality assurance related activities for the European region. You will assist the headquarters with EU regulation compliance, maintenance of product technical files and declarations of conformity. In addition to that, you will perform internal audits and host notified body audits. You will report to the General Manager of European Operations who is located in the US. This role requires to travel occasionally (

Other responsibilities:

* Support sales, post-market surveillance and attend to various other regulatory responsibilities
* Act as regulatory contact for EU Authorised Representative under the new MDR
* Coordinate and prepare EU regulatory documentation for new product releases and modifications
* Respond to inquiries from various member states (via EC Rep contact line)
* Work together with competent authorities ,within the EEC, to address the following:
* Collect information regarding incidents where the company's medical devices may have contributed to the event e.g. notification to headquarters and responses back to competent authorities and assistance with recovering devices
* Work with headquarters and competent authorities to address customer complaints
* Communicate with competent authorities to address recall/field actions
* Control records including correspondence with competent authorities and customer expectations
* Maintain awareness of new or changes to existing regulations
* Communicate legal or regulatory affairs that are updated/ changed to headquarters
* Liaise with the U.S. quality as well as U.S. and local operations team
* Work with legal teams to address local EU requirements
* Support European sales and marketing teams with navigating applicable regulatory requirements
* Train employees on various regulations and internal policies as needed

Who we're looking for: 

* A minimum of a Bachelor degree with a technical focus (e.g. Engineering or Life Sciences)
* At least 5 years of QA/RA experience in a medical, pharma or biotech environment
* Experience in MDD (93/42/EEC and its amendments) and other local regulatory requirements for medical devices including EU Technical Files, Essential Requirements and Declarations of Conformity is a plus
* Fluent in English (verbal and written)
* Ability to work detail oriented and organised under tight time lines

About our client: 

Our client FUJIFILM SonoSite B.V., located in Amsterdam, is an innovator and leader in point-of-care ultrasound. Headquartered near Seattle, the company's portable and compact systems are expanding the use of ultrasound across the clinical spectrum by bringing high-performance ultrasound to the point of patient care. The company leverages its ultrasound expertise to bring the latest technologies to the entire patient care pathway, from prevention to diagnosis and treatment. Due to the fact that FUJIFILM SonoSite B.V. is continually evolving in order to improve the lives of people around the world, we are currently exclusively looking for a RA/QA Manager who is in charge of the European region.

What's On Offer: 

* Permanent contract
* Excellent salary and secondary benefits
* Great international environment
* Professional as well as personal development opportunities

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