Johnson & Johnson's Robotics & Digital Surgery team needs to achieve US and international regulatory (NPD) approval goals for their robotic instruments and accessories portfolio.
Requirements
- Minimum of 6+ years of related Regulatory Affairs experience within Medical Device is required (4+ years with Advanced Degree).
- Experience with medical device regulatory new product submissions required.
- A demonstrated track record of developing and driving implementation of regulatory strategies.
- Working knowledge of how global regulations impact product registration.
- Previous experience with health authority meetings/interactions
- Experience with medical device software guidance, IEC 60601, sterilization, biocompatibility, and reprocessing requirements and their documentation in submissions.
Responsibilities
- Applies strategic regulatory thinking along with technical expertise to develop and implement regulatory strategies for new product clearances and approvals.
- Prepares and submits regulatory information required to obtain global market access, including preparation, writing and filing of FDA submissions (e.g., Q-submissions, IDEs, De Novo, 510(k)s) and global health authorities’ submissions technical documents.
- Serves as a Regulatory Affairs subject matter expert on new product development and engineering design control teams. This includes conducting reviews and providing expert regulatory feedback for specifications, device testing, risk management, and other relevant documentation in accordance with regulatory requirements and with positioning for regulatory submission.
- Conduct regulatory evaluation of changes to devices in accordance with requirements of commercial/operating geography and generate the required regulatory submission (including Letters To File)
- Guides conformance with applicable regulations and guidance documents in product development, support of claims, content labeling, and promotional materials.
- Assists in the development of Regulatory Affairs processes.
- Experience with medical device software guidance, IEC 60601, sterilization, biocompatibility, and reprocessing requirements and their documentation in submissions.
Other
- Instills and drives a vibrant regulatory culture, working among cross functional groups as a teammate and collaborator.
- This role will work a Flex/Hybrid schedule with 3 days per week in-office. There is NO remote option.
- Good communication skills for effective collaboration with cross-functional partners.
- Corresponding and collaborating with J&J colleagues globally for strategic contribution and achievement of regulatory milestones.
- This position will require up to 25% travel.
