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RA Manager BeNeLux

Job description

Responsible for new product registration and maintenance of existing product licenses within the Benelux cluster. Interact with Global Regulatory Affairs groups, Regional Regulatory Affairs team, Region Clinical and Medical Affairs team, GDD-RA, Benelux business leaders.

Main responsibilities:

  • Manage and organize for regulatory plans, submission, and approval of clinical trial and marketing authorization applications for all new products and life cycle management of marketed products for Belgium and The Netherlands, aligned with Global Regulatory and Region and Country business strategies and plans 
  • Responsible for establishing and management of regulatory support (0,5 FTE) in the Benelux and driving performance as measured by expeditious development of plans, regulatory submissions and approvals in the Benelux
  • Monitor operational progression of registrations activities in the Benelux through contact with country regulatory agencies or committees, as required
  • Manage and organize Health Authority requests and ccorrespondence with competent authorities, legal manufacturer and authorized representative or committees to expedite new registration authorization approvals and other operational regulatory interventions
  • Ensures all documents submitted to regulatory agencies are complete, well organized, in regulatory compliance, and presented in a manner that facilitates agency review
  • Responsible for maintaining records of regulatory submissions and communications with the relevant regulatory agencies
  • Work with commercial colleagues to support promotional strategies and provide regulatory review for promotional materials to ensure compliance with Benelux promotional regulations
  • Develop and maintain excellent working relationships with health authorities; identify regulatory risks for investigational and marketed products and develop strategies to minimize those risks
  • Keep abreast and provide regulatory intelligence on new medical device legislation, guidance and policy proposals impacting products or processes and ensure timely implementation. Provide regulatory intelligence on competitive products and companies. Notify responsible persons in organisation if local requirements differ from those in force in the EU
  • Accountable for ensuring the organization is adequately represented in relevant regulatory advocacy groups, to ensure the company position is considered as new regulations are proposed by health authorities 
  • Collaborate with QA on implementation and execution of GDP activities, field corrective actions and recalls
  • Participate in and prepare for internal and external audits and inspections as required
  • Maintaining familiairity with company product ranges
  • Manage small regulatory projects individually
  • Provide support to other projects and assignments as required

Background:

Bachelor’s degree in a related field is required (Pharmacy or other Scientific discipline).

Fluent in Dutch, French and English 

At least 3 years in Regulatory Affairs, with significant depth of experience within the

medical device industry

A track record of successful execution of regulatory submissions and approvals for

medical devices

High energy, collaborative and experience initiating and leading change

Ability to influence senior stakeholders in a global environment

Contract

Executive search

Experience

minimum 5 years

Education

Higher Scientific Degree

Languages

Dutch, English, French

Sector

Medical Devices

Region

Vilvoorde

Job type

Full-time

 
 

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