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International Regulatory Affairs Manager

priority vacature priority vacature



Join and build a new major player in the medical technology industry (Linköping, Sweden)

Het bedrijf / The company

Our client is focussing on improving treatments of burns and healing of chronic wounds. They develop, produce and sell products that are designed to be synergistic with each other and together achieve what is most desirable for the patients and society, a healed wound. They offer innovative and easily accessible medical technology products and solutions for the wound healing market globally. Their Headquarter and factory are located in Linköping Sweden and they even have globally based distributors and sales teams. The products are intended to optimize the wound healing capability of people and create cost-effectiveness for healthcare.

De functie / The role

The role as International Regulatory Affairs Manager implies responsibility for new product registrations and for the management of already completed registrations. Our client is a young company so your duties and responsibilities will be broad and varied but mainly consist of regulatory work. Within this company you will be given the opportunity to affect the direction and develop their regulatory work. Our client builds strong teams and wants everyone to feel that their job is fun and exciting.

Het profiel / Your profile

o Relevant academic degree in medicine, biology or chemistry and some years of work experience from a similar position
o Experience and knowledge about CE marking and US-FDA
o Experience in building a technical file and all of its contents
o Knowledgeable about the implementation of MDR and the new ISO13485 standard
o Experience from registering a product under US-FDA 510k is desirable
o Positive mind and attitude is an advantage
o Problem solver who sees what needs to be done and does it all the way
o High level of initiative and communication skills

Het aanbod / The offer

o A challenging job within an international environment
o Working for a young, growing company
o Broad and varied responsibilities

Reactie / Reaction

Interested? Please send your resume and motivational letter by e-mail, with reference to WL/19-085-DD, to Djamila Hagemans: info@derksenderks.nl.
For further information, please call Djamila Hagemans at number +31 (0)33 472 80 87.

An individual assessment may be part of the selection procedure.

Our client has chosen Derks & Derks Secondment & Interim as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.

If this is not quite the position you are seeking, please check http://www.derksenderks.nl/vacatures for other interesting jobs!

Solliciteer hier
Indien solliciteer hier u verwijst naar een ongeldig webadres, is de vacature (hoogstwaarschijnlijk) inmiddels vervuld. Attendeer FMF hierop

Uw referentie aan www.fmfvacatures.nl wordt gewaardeerd.
Your referral to www.fmfvacatures.nl is appreciated.


Derks & Derks
Derks & Derks
Linköping, Sweden

Geplaatst op FMF: 29 oktober 2019

Branche: Farma & Biotech
Functie: QA / regulatory
Opleidingsniveau: HBO / BSc, WO/academisch / MSc, PhD
Werkervaring: 2-5 jaar, 5-10 jaar, > 10 jaar