Make the difference as a

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.
  • Collaborate with Product Management regarding regulatory strategy and new product development
  • To review and update technical files for self-certification (i.e. class I medical devices) and certification in cooperation with a Notified body (i.e. class IIa 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 product/process requirements within the quality system
  • Provide QA/RA guidance and information to all participants involved in law’s, regulations and (ISO) standards.
  • Maintain contacts with (internal and external) clients and suppliers in relation to quality and regulatory aspects.

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

  • Minimum a Bachelor’s level degree in the scientific or technical discipline
  • Biomedical/pharmaceutical background or related education in life sciences (Medicine/Biology/Chemistry)
  • Minimum of 2 years experience in regulatory affairs of medical devices and working with quality management standards
  • Knowledge of medical device regulations and standards (MDR, ISO 13485, ISO14971, ISO 10993, etc).
  • 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!

Application process

1
Online application
Complete your profile, upload your cv and add your motivation
2
Screening
Your application will be reviewed, where applicable we may check your professional qualifications
3
1st interview
You get to know Mediq and we get to know you
4
2nd interview
Together we will dive deeper into the job and how that matches up with your talents.
5
Offer
If you and we are enthusiastic about the match we have, we make you a good offer.
6
Welcome to Mediq!
You have a new job and we love to welcome you to Mediq!