J&J Family of Companies RA SPECIALIST II - LIFECYCLE INNOVATION in Diegem, Belgium
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.
Functional and Technical Competencies:
Knowledge of Medical Device regulations
Excellent communication skills (verbal and written)
Strong organizational skills
Project management skills
Problem solving skills
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).
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
Johnson & Johnson Medical NV (7546)