Senior Regulatory Affairs Program Lead – Software, OTTAVA
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Job Description
Regulatory lead advancing Johnson & Johnson’s OTTAVA robotic surgery systems through US and international approvals. Developing strategies, FDA submissions, and compliance documentation for software-enabled medical devices.
Responsibilities:
- 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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