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RA Manager

Introduction

Regulatory Affairs is a critical function within RB: a key partner in developing the right portfolio strategy for innovation and activation in our markets.

 

The RA Manager actively engages externally with stakeholders and regulators to anticipate and credibly influence changes to the regulatory environment, and brings that regulatory intelligence back to RB to drive better informed business decisions. The role is responsible for leading the thinking internally about what is possible and put forward ideas that become reality, acting as a steward of RB brands and our company to deliver compliant and competitively positioned products to the market.

Key Responsibilities

  • RB Authorised representative in EU for Medical Devices
  • Netherlands Reference Member State Lead, for all European registration for which Netherland is the RMS. Lead and coordinate new submissions and license maintenance.
  • Lead and champion the Regulatory function within BeNeLux
  • Ensure the continued growth and development of the Regulatory Specialist team within BeNeLux
  • Work collaboratively with Snr Management both within Netherlands but also within the France/Benelux cluster in order to define and implement the regulatory strategy
  • Manage a complex and diverse set of registration/regulatory requirements across multiple markets and brands to enable the strategic delivery of a global pipeline
  • Collaborate with partner functions to agree market specific data requirements and delivery timelines
  • Develop excellent working relationships with local (regional) regulatory colleagues to facilitate aligned regulatory plans and shared learnings to ensure efficient speed to market.
  • Represent the business with external bodies and lead the external influence to position RB.

Skills & Experience

  • Educated in a scientific field or equivalent experience. Honours degree is a plus.
  • Experience in medical devices and European Medical Device Regulation is essential.
  • Regulatory experience in Medical European registration processes and deep knowledge in dossier / technical file creation and maintenance.
  • Knowledge of the Regional and European regulatory environment and how it impacts regulatory dossiers and registration.
  • Experience in European registration strategies, preparing and submitting dossiers, variations and renewals.
  • Understanding of global product development practice, rules, regulations and guidelines.
  • Experience in influence the regulatory environment, including new and emerging guidelines relevant to dossier deliveries. 
  • Fluent Dutch and English, French is a plus

Equality

In Return RB offer very competitive salaries with excellent benefits and the chance to progress your career within a truly global organisation.
RB is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other basis protected by appropriate law. All hiring decisions are made based on merit, competence and business need.


Job Segment: Medical, Medical Device, Healthcare

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