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Regulatory Affairs Specialist

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Zuid-Holland
Oud Beijerland

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HBO/WO

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Regulatory Affairs Specialist

Van16-09-2019 LocatieOud Beijerland Urenn.v.t. OpleidingHBO/WO

Regulatory Affairs Officer– Mediq Medeco B.V.

Our people are the heart of Mediq: they are the ones who improve our future by taking that extra step for the patient. With more than 4,000 motivated colleagues, we continue to work on improving the quality of life for millions of people. At this moment, we are already the homecare market leader in 12 countries within Europe, and we have the ambition to develop into one of the largest international players. We do this by starting each day with the question: how can we provide care that is even better and more affordable? That is exactly what we mean when we say: committed to your care.

Mediq has an ambitious strategy to provide better and affordable care to patients in a dynamic health care environment. Our Mediq own brands assortment and development has been defined as one of the value drivers for Mediq and therefore part of the corporate growth strategy. Product quality is essential to secure the reputation of, and trust in, Mediq own brands products. To ensure unmatched quality and value to customers and patients, Medeco BV has implemented a full annex II certification and related QA and RA department. Medeco BV is part of Mediq.

We are currently looking for a Regulatory Affairs officer at Medeco BV. Medeco BV is as manufacturer of various medical devices for the European market responsible for managing the Mediq Own Brands assortment which currently includes over 1,000 products. The team is based in Oud-Beijerland, the Netherlands and currently has its own dedicated team of approx. 20 full-time members. Medeco BV is a dynamic and ambitious international organization that, with its distinctive function, is prepared to invest in your development. We offer a pleasant informal working environment with open and transparent internal communication lines.

Where are you coming from?

Qualifications, experience and skills

The successful candidate will have extensive knowledge of regulatory aspects of medical devices and preferably 2 years proven experience in working within a regulatory environment related to manufacturing products. Biomedical / pharmaceutical university degree or a related education in life-sciences or analytical chemistry. Experience in the medical device/disposable industry is strongly preferred. Fluency in English is also required as well as strong project management skills/experience.

Where are you heading?

Your role

The RA officer is working in our RA team and is responsible for the defining and execution of regulatory affairs compliance concerning our products. Is responsible for ensuring that the product assortment and manufacturing processes are compliant with all applicable external standards and regulatory requirements (MDD, MDR, IVDD, GMP, ISO-13485, etc.). Is participating in the development, implementation, maintenance and improvement of the products. Participates in the continuous monitoring of products performance and their clinical reviews including statistical analyses.

Maintains contact with (internal and external) clients and suppliers in relation to these regulatory aspects. Is accountable to determine and implement appropriate oversight of activities to ensure regulatory compliance and adherence to the quality system. Maintains productive working relationships with internal stakeholders, product management.

The RA Officer works in close cooperation with the Regulatory Affairs Lead specialist and reports to the Head of Quality Management.  

 

Which skills can you apply?

The successful candidate will be comfortable working at pace, in a highly complex commercial environment and dealing with ambiguity. He/she will be part of the QA/RA organization and has the ability to provide high services to stakeholders. Must have a proven track record of the ability to influence others. Must have the ability to work methodically and systematically with attention to detail and manage multiple tasks at once. Is able to communicate at different levels internally as well as externally. Needs to have strong analytical skills as well as strong decision-making and problem solving skills. Must have a good sense of urgency and is deadline-oriented. Must be able to work independently within a team environment.

 

What environment you will work in?

An international environment within the health care industry. Mediq is present in 14 countries.

Our offer?

A pleasant, informal and international work environment, a result driven team and a lot of personal growth opportunities. A good salary and a competitive remuneration package.

 

Apply for this job?

If you wish to apply, please click here. For more information, you can contact Johan Verhagen (Head of Quality Management Mediq Medeco) via johan.verhagen@mediq.com.

   
Vacature delen    
08-01-2020 n.v.t. n.v.t. n.v.t.
24-12-2019 Leek n.v.t. HBO