Senior Regulatory Affairs Program Lead

Job not on LinkedIn

🔥 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

Founded 1886

🏥 Healthcare

⚕️ Healthcare Insurance

💊 Pharmaceuticals

Healthcare • Healthcare Insurance • Pharmaceuticals

Johnson & Johnson is a multinational corporation focused on innovating across multiple sectors of healthcare and medicine. With a commitment to redefining healthcare, the company merges science and technology to address complex diseases through its divisions in innovative medicine and medical technology. Its areas of focus include oncology, immunology, neuroscience, and specialty ophthalmology, as well as interventional solutions and orthopaedics. J&J is dedicated to advancing global health equity and environmental sustainability while fostering innovation, diversity, and inclusion in the workplace. The company strives to provide solutions that connect health and care for providers, patients, and communities worldwide.

📋 Description

• 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