Johnson & Johnson Careers
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RA SPECIALIST II - LIFECYCLE INNOVATION
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.
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
- 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)