Johnson & Johnson Careers

RA SPECIALIST II - LIFECYCLE INNOVATION

Diegem, Belgium
Regulatory Affairs


Job Description

Requisition ID: 1805627617W

Responsible for supporting activities that initiate and maintain international product approvals for Wave 2b and Wave 3 countries across ASP, BWI and Mentor CSS business units.

 
 

POSITION DUTIES & RESPONSIBILITIES:

Partnering closely with  other members of the Strategic Implementation Group, Dossier Excellence Group, Regional Portfolio Leads and Local Country Contacts.

  • Provides support for global re-registration and renewal efforts.
  • Providing documentation to support international registration and tender requests.
  • Prepares responses to questions and requests from global health authorities for currently marketed products.
  • Managing a significant amount of proprietary information in a confidential manner to prevent loss of intellectual property.
  • Facilitiates discussions with EMEA Supply Quality partners and EU based external manufacturers to obtain documentation to support product registrations.
  • Provides solutions to a variety of problems of moderate scope of complexity.
  • Partners with Regulatory business unit teams to ensure timely registeration of new product launches.
  • Maintains and archives all regulatory documentation.
  • Communicating Change Assessments to Wave 2b and Wave 3 markets.
  • Working closely with CSS business units to communicate Wave 2b and Wave 3 regulatory impact on Change Assessments.
  • Laising with other SIG/RPL collaegues to align on MD RALI Change Assessment process.
  • Provides input to Supply Chain where necessary regarding Wave 2b and 3 markets.
  • Leverages a working knowledge of the regulatory environment, including compliance, regulations and proposed changes.
  • Laising with the Planning group to ensure product registrations are executed to plan.
  • Supports RALI activities and processes to support the CSS businesses.


Qualifications

Functional and Technical Competencies:

  • Knowledge of Medical Device regulations
  • Excellent communication skills (verbal and written)
  • Strong organizational skills
  • Project management skills
  • Problem solving skills
  • Presentation skills

Leadership Competencies:

  • Connect - Successfully 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).

  1. EDUCATION & EXPERIENCE REQUIREMENTS:
  • Minimum of a B.A. /B.S. within a technical related discipline is prefered. 
  • Minimum of 2 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
 


Primary Location
Belgium-Brussels-Capital Region-Diegem
Organization
Johnson & Johnson Medical NV (7546)
Job Function
Regulatory Affairs
Requisition ID
1805627617W