Senior Regulatory Affairs Specialist
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Job Description
Senior Regulatory Affairs Specialist advancing FDA and global approvals for Johnson & Johnson’s OTTAVA medical-device robotics group. Authoring submissions and shaping regulatory strategies.
Responsibilities:
- Support the Instrumentation & Accessories team under the OTTAVA robotics group
- Help Robotics & Digital Solutions reach US and international regulatory new product development approval goals
- Address regulatory affairs needs for robotics, instruments, and accessories portfolios
- Work with engineering and clinical teams during product development stages
- Generate submission-ready documentation and author regulatory submissions
- Support health authority communications
- Participate in regulatory strategy development
- Implement regulatory strategies for new product clearances and approvals
- Prepare, write, and file FDA submissions, including 510(k)s, and global health authority technical submissions
- Identify issues, communicate project timelines, and address issues affecting registration status
- Guide conformance with regulations and guidance documents for product development, claims, labeling, 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 4+ years of related Regulatory Affairs experience within Medical Device required; 3+ 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
- Ability to correspond and collaborate with J&J colleagues globally
- Ability to evaluate new regulatory requirements and regulatory changes and assess business impact
- Excellent verbal and written communication skills; strong attention to detail
- High organization skills with ability to lead multiple projects/tasks and prioritize effectively
- Strong learning skills for complex technology and presentation skills to present complex regulatory strategies clearly
- Up to 25% travel required
- Previous experience with health authority meetings/interactions preferred
- Experience with medical device software guidance, IEC 60601, sterilization, biocompatibility, and reprocessing requirements preferred
Benefits:
- Consolidated retirement plan (pension)
- Savings plan (401(k))
- Vacation – 120 hours per calendar year
- Sick time – 40 hours per calendar year; 48 hours for Colorado employees; 56 hours for Washington employees
- 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
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