Senior Regulatory Affairs Program Lead

🔥 0 minutes ago

🏄 California, New Jersey, +1 more states – Remote

🏄 California – Remote 🏖️ New Jersey – Remote 🏈 Ohio – Remote

💵 $109k - $174.8k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Johnson & Johnson

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💊 Pharmaceuticals

🧬 Biotechnology

Healthcare • Pharmaceuticals • Biotechnology

<Johnson & Johnson> is a global healthcare company that researches, develops, manufactures and markets pharmaceuticals, medical devices and consumer health products. The company focuses on innovative medicines and therapies across oncology, immunology, neuroscience and cardiopulmonary areas, and develops MedTech solutions in cardiovascular, orthopaedics, surgery and vision. Johnson & Johnson also engages in health & wellness education, large-scale manufacturing, investor activities and global social-impact initiatives.

📋 Description

• Support the Instrumentation & Accessories team under the OTTAVA robotics group • Lead regulatory strategy development and execution for the robotic instruments and accessories portfolio • Help achieve US and international regulatory new product development approval goals • 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 • Prepare, write, and file FDA submissions, including Q-submissions, IDEs, De Novo, and 510(k)s • Prepare global health authority technical submissions • Serve as Regulatory Affairs subject matter expert on new product development and engineering design control teams • Review specifications, device testing, risk management, and other documentation for regulatory compliance and submission readiness • Identify issues, communicate project timelines, and address issues affecting registration status • Evaluate device changes according to commercial/operating geography requirements and generate required submissions, including Letters To File • Guide compliance with regulations and guidance for product development, claims, labeling, and promotional materials • Assist in developing Regulatory Affairs processes • Collaborate globally to achieve regulatory milestones • Travel up to 25%

🎯 Requirements

• Minimum of a Bachelor's Degree required; advanced degree highly desired; desired areas include Science, Engineering, or related field • Minimum of 6+ years of related Regulatory Affairs experience within Medical Device required, or 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 and presentation skills for complex technology and regulatory strategies • Ability to travel up to 25% • Previous experience with health authority meetings/interactions • Experience with medical device software guidance, IEC 60601, sterilization, biocompatibility, reprocessing requirements, and related submission documentation

🏖️ 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 • Bay Area base pay range of $125,000.00–$201,250.00 for applicable employees