J&J Family of Companies Regulatory Affairs Manager, EU Strategy in Diegem, Belgium
Position Title: regulatory Affairs Manager, EU Strategy
Sector: Medical Devices
Location: Wokingham or Diegem
Closing Date: 24th July 2017
The Manager, EU Regulatory Affairs executes the RA franchise strategy for CE Marking, supports EU country registrations, monitors and impacts product specific regulations.
The Manager, EU Regulatory Affairs develops and implements regulatory strategies and processes to assure timely commercialization of products in the EU in compliance with applicable European Regulations
The Manager, EU Regulatory Affairs is responsible to support daily RA activities related to products under his/her area
Works with team member and commercial partners to oversee the regulatory aspects for obtaining regulatory approval of new products with the following responsibilities:
Demonstrate/develop deep domain expertise in the regulatory requirements for CE-marking of franchise products
Prioritize with marketing and commercial partners the registration of Franchise products in the EU
Provide training on products or franchise processes to countries as appropriate
Ensure regulatory affairs procedures are maintained and up to date
Provide training on EU regulations and requirements to franchise teams
Support introduction of franchise products into the EU supply chain
Support NB and EU authority audits as appropriate
Conduct regulatory assessment for EU requirements
Review global RA strategies and determine strategies for CE marking
Liaise as appropriate with the RALI team for CSS products handled by RALI
Clearly and timely communicating new requirements to the franchise regulatory team
Manages the relationship to the notified body on technical level
Interacts with relevant competent authorities in the region on behalf of the franchise
Partners closely with internal partners across Johnson & Johnson (including regional franchise Marketing Lead, Clinical and Med Affairs) to ensure that the stakeholders' voices are evaluated within the strategies
Represents CSS in various internal and external forums for the franchise
Serves as a CE marking SME for the portfolio
Performs other duties assigned as needed
Functional and Technical Competencies:
Strategic thinking and ability to partner and Influence key stakeholders.
Expert knowledge of regulatory requirements in the EU and ability to translate regulations into clear data requirements to support CE-marking
Ability to persuasively communicate with notified bodies technical reviewers, and EU registration officers
Highly skilled in establishing partnerships with regional colleagues
A strong results-orientation and sense of urgency
Fluent in English (required) and in another European language (desired)
Bachelor’s degree in a relevant field
Adequate experience in EU regulatory requirements for medical devices required.
What type of mark will you make?
Your unique talents and perspective can make a vital contribution to innovative products that improve the lives of people everywhere. Career opportunities within Johnson & Johnson companies may provide you with an ideal setting to build your leadership experience; express your passion and touch the world.
If you decide to apply for the position, any personal data which you provide shall be processed by Johnson & Johnson. Your personal data shall be processed for the purposes of recruitment, recruitment policy and selection.
We respectfully request Government Officials to identify themselves as such on application; for the purposes of the Foreign Corrupt Practices Act.
Europe/Middle East/Africa-Belgium-Brussels-Capital Region-Diegem
Johnson & Johnson Medical Ltd. - fka -Ethicon Ltd. (7355)