[Medical Devices] - Transformation RA Specialist(Contractor)
Location: Asia Pacific-China-Hong Kong S.A.R.-Mongkok
Johnson & Johnson is the world's most comprehensive and broadly based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical, and medical devices and diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.
- Responsible for finalizing the preparation of Standard Technical Dossier (STED) for initial registrations, product changes, re-registrations and renewals to support Medical Devices products from multiple business units in APAC countries.
- Assists with preparing necessary information for regulatory submission and prepares general local documentation, forms, and transactions required for final submission in countries as assigned.
POSITION DUTIES & RESPONSIBILITIES:
- Compiles information and documentation for routine submissions to APAC local countries regulatory bodies for multiple business units.
- Ensures collection of all related documentation as required to receive agency approvals or in response to agency requests.
- Provides basic information to various departments regarding submission requirements and standards to facilitate efficient processing by agencies.
- Organizes and prioritizes submissions that need review to ensure they meet paper and electronic regulatory submission standards, policies and operating procedure requirements.
- Organizes and prioritizes regulatory submissions to be reviewed for compliance with submission standards.
- Ensures compliance with regulatory agency regulations and interpretations.
- Prepares responses to regulatory agencies' questions and other correspondence as requested.
- Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
- Involved with the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
- Provides solutions to a variety of problems of moderate scope and complexity.
Functional and Technical Competencies (critical competencies in bold italics):
- Excellent communication skills (verbal and written) in English
- Presentation skills
- Strong organizational skills
- Project management skills
- Problem solving skills
- Connect - Strongly influences others by partnering with them effectively; persists in the face of challenges.
- Shape: Challenge the status quo and adapting to change, taking advantage of opportunities to have a positive impact
- Lead: Utilizes strategic thinking and intellectual curiosity to generate effective ideas or solutions
- 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:
- University/Bachelors degree or equivalent is required. Degree within a technical related discipline is preferred.
- 2 years of related experience is preferred.
- Ability to work both independently and in a team environment.
- Ability to problem solve, recognize and find solutions for gaps in processes
- A combination of background, education and experience can be considered.
- Project Management