Senior Regulatory Affairs Program Lead (Software/OTTAVA)
Johnson & Johnson Innovative Medicine
Summary
We are searching for the best talent for a Senior Regulatory Affairs Program Lead to support our OTTAVA robotics group. Preference will be given to candidates located within a commutable distance of Santa Clara, CA however remote options will be considered on a case-by-case basis and if approved by the company.
Job description
Purpose
In joining our growing regulatory team, the Sr. Regulatory Affairs Program Lead will help OTTAVA reach US and international regulatory (NPD) approval goals. Under minimal supervision, the selected candidate will lead regulatory strategy development and execution for the robotic systems portfolio. They will work closely with exceptional engineering and clinical teams, supporting product development stages, generating submission ready documentation, and authoring regulatory submissions. Additionally, this individual will support health authority communications.
Responsibilities
- Prepare and execute regulatory strategies for NPD and LCM projects.
- Serve as strategic regulatory lead across product development, submission, approval, and LCM activities.
- Serves as a regulatory SME on cross-functional partners with strong knowledge of electromechanical devices with software enabled functionality. Responsibilities include conducting reviews and providing expert regulatory feedback for specifications, device testing, risk management, labeling and other relevant documentation in accordance with regulatory requirements and with positioning for regulatory submission.
- Prepare and submits regulatory information required to obtain timely US market access, including preparation, writing and filing of FDA submissions (e.g., Q-submissions, IDEs, De Novo, 510(k)s). Lead FDA meeting preparation.
- Executes sustaining activities including change assessments, Letter To File, registrations and renewals.
- Support global health authorities’ submissions technical documents.
- Applies expert knowledge of guidances, regulations, and standards relevant to product portfolio.
- Support audits.
Requirements
- Minimum of a Bachelor’s degree required
- Advanced Degree strongly preferred
- At least 6+ years of regulatory affairs experience in medical devices including experience with software-enabled systems
- Proven track record of securing regulatory approvals (e.g., 510ks, IDEs, De Novos)
- Proven ability to be highly collaborative & flexible – comfortable navigating through ambiguity
- Excellent cross‑functional communicator; able to influence within the regulatory team and across functions
- Independent strategic thinker, able to synthesize regulatory pertinent information (guidances, regulations, trends., etc.) to provide regulatory strategy that drives towards business priorities/needs
- Advanced problem-solving skills
- Experienced in evaluating new regulatory requirements as well as regulatory changes for projects impact
- Experienced leading multiple projects with complex level of detail
- Experience supporting US market
- This position may require up to 10% travel
- Previous experience health authority meetings and preparation for meetings
- Experience with vision systems, robotics, and connected medical platforms
- Experience with IEC 60601 series and ISO 10993-1
- Strong knowledge of FDA software and cybersecurity regulatory requirements
Benefits
- Pension
- 401(k)
- Vacation
- Sick time
- Holiday pay
- Floating holidays
- Parental leave
- Bereavement leave
- Caregiver leave
- Volunteer leave
- Military spouse time-off
Company overview
Johnson & Johnson Innovative Medicine is the pharmaceutical division of Johnson & Johnson, leading the way in medical innovation with a relentless focus on bringing transformational treatments to patients worldwide. The company applies rigorous science and compassion to address the most complex diseases of our time, developing groundbreaking medicines across key therapeutic areas including oncology, immunology, neuroscience, and cardiopulmonary medicine. With deep expertise and global reach, Johnson & Johnson Innovative Medicine reimagines how devastating diseases are treated and cured, delivering hope and better care for millions of patients and their families. The organization pioneers the path from laboratory research to clinical application, championing patients every step of the way while maintaining an unwavering commitment to scientific excellence and patient-centered innovation.