Senior Regulatory Affairs Program Lead – MedTech Surgery

Job not on LinkedIn

🔥 1 minute 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

🏥 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

• Lead regulatory strategy development and execution for the OTTAVA robotic systems portfolio • 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 and provide regulatory feedback on 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 expert knowledge of relevant guidances, regulations, and standards • Support audits • Work closely with engineering and clinical teams to support product development and submission-ready documentation • Support health authority communications

🎯 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 regulatory and across functions • Independent strategic thinking and ability to synthesize guidances, regulations, and trends into regulatory 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: previous 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

• Retirement plan (pension) • Savings plan (401(k)) • Vacation – 120 hours per calendar year • Sick time – 40 hours per calendar year; 48 hours for employees residing in Colorado; 56 hours 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