Senior Regulatory Affairs Program Lead – MedTech Surgery

Job not on LinkedIn

🔥 17 hours ago

🏄 California – Remote

🏄 California – Remote

💵 $125k - $201.3k / 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 OTTAVA robotics group in achieving US and international regulatory approval goals • Lead regulatory strategy development and execution for the robotic systems portfolio • Collaborate with engineering and clinical teams throughout product development • Generate submission-ready documentation and author regulatory submissions • Support health authority communications • Prepare and execute regulatory strategies for NPD and LCM projects • Serve as strategic regulatory lead across product development, submission, approval, and LCM activities • Act as regulatory subject-matter expert for electromechanical devices with software-enabled functionality • Review specifications, device testing, risk management, labeling, and related documentation • Prepare, write, and file FDA submissions, including Q-submissions, IDEs, De Novo submissions, and 510(k)s • Lead FDA meeting preparation • Execute sustaining activities, including change assessments, Letters to File, registrations, and renewals • Support technical documents for global health authority submissions • Apply regulatory guidance, regulations, and standards relevant to the product portfolio • Support audits

🎯 Requirements

• Minimum of a Bachelor’s degree required • At least 6+ years of regulatory affairs experience in medical devices, including experience with software-enabled systems • Proven track record of securing regulatory approvals, such as 510(k)s, IDEs, and De Novos • Highly collaborative and flexible; comfortable navigating ambiguity • Excellent cross-functional communication and ability to influence within the regulatory team and across functions • Independent strategic thinking and ability to synthesize regulatory-relevant information to develop business-aligned strategy • Advanced problem-solving skills • Experience evaluating new regulatory requirements and regulatory changes for project impact • Experience leading multiple complex projects • Experience supporting the US market • May require up to 10% travel • Preferred: health authority meeting experience and preparation • Preferred: experience with vision systems, robotics, and connected medical platforms • Preferred: experience with IEC 60601 series and ISO 10993-1 • Preferred: strong knowledge of FDA software and cybersecurity regulatory requirements

🏖️ Benefits

• Consolidated retirement plan (pension) • Savings plan (401(k)) • Vacation – 120 hours per calendar year • Sick time – 40 hours per calendar year; 48 hours per calendar year for employees residing in Colorado; 56 hours per calendar year for employees residing in Washington • 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 • Remote work option