Senior Regulatory Affairs Program Lead – Software, OTTAVA

Job not on LinkedIn

🔥 15 hours ago

🏄 California, Ohio – Remote

🏄 California – Remote 🏈 Ohio – Remote

💵 $112k - $180.6k / year

⏰ Full Time

🟠 Senior

🧑‍💻 Full-stack Engineer

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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

• 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 SME for electromechanical devices with software-enabled functionality • Review and provide expert 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 global health authority submission technical documents • Apply expert knowledge of guidances, regulations, and standards relevant to the product portfolio • Support audits • Work closely with engineering and clinical teams to support product development, generate submission-ready documentation, and author regulatory submissions • Support health authority communications

🎯 Requirements

• Minimum of a Bachelor’s degree required • At least 6+ years of regulatory affairs experience in medical devices, including software-enabled systems • Proven track record of securing regulatory approvals, such as 510(k)s, IDEs, and De Novos • Proven ability to be 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 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 projects with complex levels of detail • Experience supporting the US market • May require up to 10% travel • Preferred: previous health authority meetings and meeting 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 Colorado residents; 56 hours for Washington residents • 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

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