Senior Regulatory Affairs Program Lead – MedTech Surgery

Job not on LinkedIn

🔥 4 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 • 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