Senior Regulatory Affairs Program Lead – Software, OTTAVA

Johnson & Johnson

. Prepare and execute regulatory strategies for NPD and LCM projects .

Posted 11/11/2026full-timeRemote • United StatesSenior💰 $112,000 - $180,550 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory strategies for new product development and lifecycle management in medical devices, with a strong focus on FDA submissions and compliance with relevant regulations and standards.

Highest-signal resume keywords

Regulatory Affairs ExperienceFDA SubmissionsMedical DevicesStrategic Regulatory LeadCross-Functional Communication

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy DevelopmentFDA Submission PreparationRisk ManagementDevice TestingRegulatory DocumentationChange AssessmentsRegulatory ApprovalsGuidance SynthesisRegulatory Requirements EvaluationProject Management

Soft Skills

CollaborativeFlexibleIndependent Strategic ThinkingAdvanced Problem-SolvingInfluencing Skills

Tools & Technologies

Electromechanical DevicesSoftware-Enabled SystemsVision SystemsRoboticsConnected Medical Platforms

Industry Keywords

FDA510(k)IDEDe NovoIEC 60601ISO 10993-1Health Authority CommunicationsRegulatory StandardsMedical Device RegulationsCybersecurity Regulatory Requirements

Tech Stack

Tools & technologies

Cyber Security

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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