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

Position Summary

 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

Duties/ Responsibilities

 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)

Qualifications

Education/ Experience

 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.

Primary Location

United Kingdom-England-Wokingham

Other Locations

Europe/Middle East/Africa-Belgium-Brussels-Capital Region-Diegem

Organization

Johnson & Johnson Medical Ltd. - fka -Ethicon Ltd. (7355)

Job Function

Regulatory Affairs

Requisition ID

1700181092W