Senior Regulatory Affairs Program Lead
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Job Description
Regulatory Affairs Program Lead advancing Johnson & Johnson OTTAVA surgical robotics approvals. Leading global submissions, product strategies, and health authority interactions.
Responsibilities:
- Support the Instrumentation & Accessories team under the OTTAVA robotics group
- Help OTTAVA reach US and international regulatory (NPD) approval goals
- Lead regulatory strategy development and execution for the robotic instruments and accessories portfolio
- Work with engineering and clinical teams throughout product development stages
- Generate submission-ready documentation and author regulatory submissions
- Support health authority communications
- Drive a vibrant regulatory culture across cross-functional groups
- Develop and implement regulatory strategies for new product clearances and approvals
- Prepare, write, and file FDA submissions, including Q-submissions, IDEs, De Novo, and 510(k)s, as well as global health authority technical submissions
- Serve as a Regulatory Affairs subject matter expert on new product development and engineering design control teams
- Review specifications, device testing, risk management, and related documentation for regulatory compliance and submission positioning
- Identify issues, communicate project timelines, and address complex issues affecting registration status
- Evaluate device changes and generate required regulatory submissions, including Letters To File
- Guide conformance with regulations and guidance documents in product development, claims support, labeling content, and promotional materials
- Assist in developing Regulatory Affairs processes
Requirements:
- Minimum of a Bachelor's Degree required; 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 ability to lead multiple projects/tasks simultaneously and prioritize effectively
- Strong learning skills for complex technology and presentation skills for explaining 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 documentation in submissions
Benefits:
- Retirement plan (pension)
- Savings plan (401(k))
- Vacation – 120 hours per calendar year
- Sick time – 40 hours per calendar year
- 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 the 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
- Up to 25% travel
- Remote options considered on a case-by-case basis
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