Johnson & Johnson Careers

Regulatory Affairs Manager Lifecycle Innovation

Allschwil, Switzerland
Regulatory Affairs


Job Description

Requisition ID: 1805680893W

"Caring for the world… one person at a time” inspires and unites the people of Johnson & Johnson. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo.¨



DePuy Synthes Companies of Johnson & Johnson is the largest, most comprehensive orthopedic and neurological business in the world. DePuy Synthes offer an unparalleled breadth and depth of technology, devices, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, cranio-maxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we created one organization that will be agile and better equipped in today’s evolving health care environment. Our broad array of inspired, innovative and high-quality offerings help advance the health and wellbeing of people around the world. 


We are currently looking for for a:

Responsible for supporting the planning and execution of registration strategies and lifecycle management of  Medical Device products across designated Portfolio(s) in RALI-supported countries within EMEAC (Europe, Middle East, Africa and Canada).


We are currently looking for for a:

 

RA Manager - Lifecycle Innovation

 
Position Duties and Responsibilities
 

Responsible for supporting the planning and execution of registration strategies and lifecycle management of  Medical Device products across designated Portfolio(s) in RALI-supported countries within EMEAC (Europe, Middle East, Africa and Canada).

  • Assist country teams in developing registration strategies to accelerate speed-to-market;
  • Partner with the EMEA Strategy & Innovation Lead in ensuring registration plans within the RALI-supported markets in EMEAC for designated portfolio(s) align with Regional Marketing launch plans for New Product Introductions;
  • Serve as the Regulatory Project Lead as required for complex variations, new product introductions, acquisitions and divestments impacting the designated portfolio in EMEAC RALI-supported markets as required and aligned with the Head of Regulatory Affairs for EMEAC.
  • Monitor the completion of all requests for change impact assessments originating from the Business Units for the designated portfolio(s) in EMEAC RALI-Supported countries.
  • Drive lifecycle management by analyzing renewals against NPIs to recommend areas of portfolio rationalization
  • Coordinate the Cycle Planning process for designated portfolio(s) in EMEAC RALI-supported markets to gather and prioritise registration plans for all submission types (aligning with the Strategy & Innovation Lead for EMEAC), guide the entry of RA Strategies and RA Actions into MDRIM, and work with RALI Execution teams responsible for delivering supporting documentation to markets to obtain timely documentation for registration, and compliance with regulatory strategy and local regulations.
  • Monitor and report submission and approval timelines against defined RALI metrics and utilize business Insight to improve performance.
  • Work with RALI colleagues to develop and implement streamlined, consistent processes for both new products and life cycle management through best-practice sharing and continuous improvement, to reduce risk and drive regulatory compliance.
  • Participate in developing and executing exciting programs to strengthen talent development and pipeline across RALI and EMEAC RALI-supported Markets.
  • As required, assist markets to assess and communicate new/changed regulatory requirements to Stakeholders





Qualifications
  • Solid knowledge of regulatory requirements in EMEAC RALI-supported markets (Canada, GCC, MISSA, Middle East) and the ability to articulate  country requirements to multiple audiences and to translate regulations into clear data requirements to support registrations
  • Highly skilled in establishing partnerships with regional colleagues, successfully influence functional leaders of all levels and able  to work collaboratively in a highly matrix environment
  • Demonstrated strong leadership, organizational, and planning skills with the ability to work cross-functionally with a diverse work force and customer base.
  • A strong results-orientation and sense of urgency whilst demonstrating proficiency and success in prioritizing and handling multiple projects simultaneously
  • strong business acumen and presentation skills; comfortable presenting to senior regional leaders
  • Strong analytical and process improvement skills
  • Must be able to communicate clearly, succinctly and effectively over the phone and in writing in English.

Leadership Competencies:

 
  • CONNECT by cultivating strong internal  partnerships and collaborations through transparent and constructive conversations, contributing to high-performing teams within  RALI and across business functions
  • SHAPE by translating country-specific and/or regional insights into innovative and viable solutions, adding value to RALI and the business.
  • LEAD by driving a thorough understanding of local regulatory requirements in Wave 3 countries relevant to the designated portfolio(s) across regional key stakeholders, and RALI organization
  • DELIVER a robust and well communicated regulatory strategy for designated portfolios across Wave 3 countries thus positioning the business to achieve both short-term and long-term results.
  1. EDUCATION & EXPERIENCE REQUIREMENTS:
 

Minimum of 8 years of medical device, diagnostic or related industry experience.

 
  • Experience shall include relationship building, negotiation, management and a proven track record of strategic thinking.  Also needed, is an in depth knowledge and hands on experience obtaining regulatory approval for a wide range of Medical devices. Experience in Pharmaceutical and Biologic products desirable.
  • Demonstrated expertise and knowledge and understanding of applicable Regional,  US and international medical device regulations.
  • Demonstrated ability to set effective business, technical and/or regulatory direction.
  • Demonstrated experience of managing multiple franchise projects simultaneously and consisting of varying degrees of complexity.
  • Masters degree or equivalent required.
  • Advanced computer skills
  • Excellent English skills (verbal, written and on phone) and Bi-lingual preferred (LATAM: Fluent in English and Spanish), APAC: Cantonese, Mandarin and/or Bahasa desirable, EMEA: Arabic)

If you feel attracted by this challenge and want to be part of a successful and growing organization, then please send us your online application (CV, Motivation Letter, Working References etc.) by clicking here.

 

Please click on DePuy Synthes and Johnson & Johnson if you want to learn more about our business and check our new career channel on YouTube  www.youtube.com/user/CareersAtJNJ to understand our working culture!



Primary Location
Switzerland-Allschwil-
Organization
Synthes GmbH (7111)
Job Function
Regulatory Affairs
Requisition ID
1805680893W