Regulatory Affairs

Jobinhalt

As a Regulatory Affairs Manager you are responsible for the strategic and operational management of the regulatory aspects of substance based medical devices, food supplements and biocides. A lot of regulatory activities are outsourced to specialized external providers (e.g. activities for our US brand RID, all EU biocide and EPA work). You are responsible for the planning, preparation and compliance of these activities. You advise and guide the R&D project managers regarding the above aspects.

The company specializes in the innovation of consumer healthcare products and especially in over-the-counter products (OTC). Our mission is to bring to the world new health products that combine scientific progress with consumer insights to improve people’s lives and health. The Company develops these innovations for its two business units: sales to third party customers (xxx Laboratories) and sales from own brands in a selection of categories: head lice treatment, insect control and premium dietary supplements (XXX Consumer Health).

In This Role, Your Primary Tasks Are

• Manage regulatory activities for medical devices, biocides and food supplements
• Contact with regulatory authorities and notified bodies
• Prepare and supervise regulatory audits
• CE certification of medical devices
• Prepare technical dossiers for medical devices
• Support our customers with the submission of our technical dossiers
• Regulatory input in QMS system of The Company
• Regulatory input in R&D projects
• Vigilance Oversight
  

You will be working in the Innovation Lab team with 2 other colleagues, reporting to the Head of Regulatory.

• Master of Science in a life science discipline
• More than 3 years of experience as a Regulatory Affairs Manager
• Experience with EU Medical Device Regulation is strictly necessary. Other relevant regulatory matters such as EU Biocides, USA FDA 510(k) , dietary supplement regulation, cosmetics, can be acquired on the job.
• Good analytic mind and pragmatic approach to Regulatory Affairs issues
• Academic English, knowledge of Dutch and any other language is a plus
• Knowledge of the current Office applications. Experience with an ERP package is required.
• You are proactive and anticipate possible obstacles; you look for accurate solutions when necessary
  

Very interesting salary package