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Regulatory Affairs Specialist

Medeco BV is looking for a regulatory affairs team member. We are a medical device manufacturer in Europe with a wide portfolio of products to be used by healthcare professionals. Patients health and safety is our prime focus in the environment of the aging European population. We are actively supporting the growth of our business in the Mediq group, our mother company. For the essence of compliance in the legal frame work of the European medical device regulation and with all related authorities are we continuously monitoring and improving our documentation and proof of effectiveness.

What are you going to do?

Your position as a Regulatory Affairs Specialist is in our Quality Management team where we always have various projects on the agenda. Regulatory affairs for medical devices is a wide area with a wide range of expertise in clinical and in technical aspects.

Your main responsibilities consists of:

  • Collecting, registering, maintaining and distributing technical files for private label products in accordance with applicable laws and regulations.
  • To review and update technical files for self-certification (i.e. class 1 medical devices) and certification in cooperation with a Notified body (i.e. class Is medical devices).
  • Monitoring external changes to the related standards and assess impact for Medeco B.V.
  • Giving support and audit Medeco B.V. quality system based on internal and external requirements and developments.
  • Support internal stakeholders with respect to the required quality system for products.
  • If required provide QA/RA information to all participants involved in law’s, regulations and standards.
  • Maintain contacts with (internal and external) clients and suppliers in relation to quality and regulatory aspects.

What is your background?

What is your background?

You are looking for the next step in your career and looking to work in a dynamic international team where you further build up your career in the regulatory environment. Next to that you are a talented professional with preferably toxicological experience.

Education & Experience

  • Academic grade or work- and intellectual level.
  • Biomedical/farmaceutical background or related education in life-sciences or analytical chemistry and toxicology assessments.
  • Knowledge of regulatory aspects of medical devices and preferably 2 years proven experience in working within a quality systems, and quality measurement standards
  • Awareness of law’s, regulations and standards (MDR, ISO-13485, etc) for the product assortment available within the group (medical devices, personal protection) & manufacturing processes of suppliers.
  • Knowledge and experience with quality systems and their certification methods.
  • Experience with or interested in technical file preparation and maintenance for products, processes and systems.
Knowledge and experience to support the regulatory aspects related to medical devices during the product life-cycle, like vigilance, monitoring, complaints.
Medeco

Medeco

Op locatie Oud-Beijerland, waar Mediq Institutionele zorg (Mediq Medeco) en Medeco BV te vinden zijn, worden we gedreven door wat er in de praktijk gebeurt. Onze mensen hebben een achtergrond in de zorg en weten wat er speelt. We gaan regelmatig met klanten in gesprek om te horen wat klanten echt bezighoudt. Bij het bepalen van ons assortiment en het ontwikkelen van diensten is daarom ook ons credo: Inleven. Oplossen. Doen!

Sourcing

The sourcing team enables Mediq to outperform competition by growth, profitability and value creation via the external supply base. It is a strategic function that leverages the scale of Mediq, drives tangible impact to the bottom line and enables new revenue streams via innovation and commercial partnerships. We continuously benchmark the internal organization against external best practices and mobilize the organization for change. And lead all commercial supplier communication and are committed to fair awarding, compliance and to tangible cost improvements.

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Sollicitatieprocedure

1
Online solliciteren
Leuk dat je interesse hebt! Solliciteren bij Mediq is eenvoudig. Upload jouw motivatie en CV via de sollicitatielink onderaan de vacature.
2
Screening
Daarna volgt een korte screening en hoor je of wij een mogelijke match zien. Onderdeel van de screening kan bijvoorbeeld een check zijn op VOG, diploma's of een referentiecheck. Dit kan ook op een later moment plaatsvinden.
3
1e gesprek
Tijdens het eerste gesprek ga je uitgebreid kennismaken met Mediq en wij met jou.
4
2e gesprek
In het vervolggesprek gaan we nog een stapje verder op de inhoud en in sommige gevallen wordt er gebruik gemaakt van een casus.
5
Aanbod
Als jij, en wij, enthousiast zijn over elkaar dan volgt er een mooi aanbod.
6
Aan de slag
De arbeidsovereenkomst is helemaal rond en je gaat aan de slag bij Mediq. Welkom!

Solliciteer op deze vacature

Solliciteer nu als jij interesse hebt in deze vacature! Zorg dat je de documenten klaar hebt staan om toe te voegen aan je sollicitatie.