Job Detail

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 are creating 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.

 For our site in Zuchwil-Switzerland we are looking for a highly committed  
RA Specialist II - Lifecycle Innovation  1. Overall responsibilities

Responsible for supporting activities that initiate and maintain international product approvals for Wave 2b and 3 countries for Global Orthopaedics.

2. Position duties and responsibilities

Partnering closely with other members of the Strategy Implementation Group, Dossier Excellence,

Regional Portfolio Leads and Regulatory Operations teams.

Provides support for Wave 2b and 3 market registrations and license renewals.

Providing documentation to support international registration and tender requests.

Prepares responses to questions and requests from health authorities for product registrations.

Managing a significant amount of proprietary information in a confidential manner to prevent

loss of intellectual property.

Ensures compliance with regulatory agency regulations and interpretations

Provides solutions to a variety of problems of moderate scope of complexity.

Maintains and archives all regulatory documentation.


Qualifications

BA. /B.S. Degree preferred or equivalent work experience.

• Minimum of 2 to 4 years of related experience preferably Medical Devices or Pharmaceuticals


• Ability to work both independently and in a team environment.


• Ability to problem solve, recognize and find solutions for gaps in processes.


• Knowledge of Medical Device regulations


• Excellent communication skills (verbal and written)


• Strong organizational skills


• Project management skills


• Problem solving skills


• Presentation skills


• Connect -Effectively influences others by partnering with them effectively; persists in the face of challenges.


• Shape -Develops an understanding of relevant competitor products, strategies, and market segmentation. Researches and reports on the Regulatory activities of competitors


• Lead -Listens to and understands others’ points of view; develops an understanding of others’ motivations, needs and concerns.


• Deliver -Manages specific project steps to deliver required objectives independently/or with some supervision or as part of a team (for example, managing individual aspects of regulatory
  submissions).


• English: Business fluent


• German: fluently

Primary Location

Switzerland-Solothurn-Zuchwil-


Organization

Synthes GmbH (7111)


Job Function

Regulatory Affairs


Requisition ID

1905727685W