Senior Regulatory Affairs Program Lead – MedTech Surgery
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Job Description
Regulatory Affairs Lead advancing Johnson & Johnson’s OTTAVA robotic instruments and accessories approvals. Developing global strategies, authoring FDA submissions, and guiding product teams.
Responsibilities:
- Support the Instrumentation & Accessories team under the OTTAVA robotics group
- Lead regulatory strategy development and execution for robotic instruments and accessories
- Support US and international regulatory new product development approval goals
- Work with engineering and clinical teams throughout product development
- Generate submission-ready documentation and author regulatory submissions
- Support health authority communications
- Prepare, write, and file FDA submissions, including Q-submissions, IDEs, De Novo, and 510(k)s
- Prepare global health authority technical submission documents
- Serve as a Regulatory Affairs subject matter expert on product development and engineering design control teams
- Review specifications, device testing, risk management, and related documentation
- Identify issues, communicate project timelines, and address issues affecting registration status
- Evaluate device changes and generate required regulatory submissions, including Letters To File
- Guide conformance with regulations and guidance in product development, claims, labeling, and promotional materials
- Assist in developing Regulatory Affairs processes
- Collaborate across functions and globally to achieve regulatory milestones
Requirements:
- Minimum of a Bachelor's Degree required; Advanced Degree highly desired; desired areas of study include Science, Engineering, or related field
- Minimum of 6+ years of related Regulatory Affairs experience within Medical Device required (4+ years with Advanced Degree)
- Experience with medical device regulatory new product submissions required
- Demonstrated track record of developing and driving implementation of regulatory strategies
- Working knowledge of how global regulations impact product registration
- Good communication skills for effective collaboration with cross-functional partners
- Experience evaluating new regulatory requirements and regulatory changes and assessing business impact
- Excellent verbal and written communication skills; strong attention to detail
- Advanced analytical and problem-solving skills
- High organization skills with the ability to lead multiple projects/tasks simultaneously and effectively prioritize
- Strong learning skills for complex technology and presentation skills to present complex regulatory strategies clearly, concisely, and comprehensively
- 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
- Willingness and ability to travel up to 25%
Benefits:
- Pension plan
- 401(k) savings plan
- Vacation – 120 hours per calendar year
- Sick time – 40 hours per calendar year; Colorado residents – 48 hours; Washington residents – 56 hours
- Holiday pay, including Floating Holidays – 13 days per calendar year
- Work, Personal and Family Time – up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
- Remote work options
- Up to 25% travel
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