New · posted Nov 12
Johnson & Johnson · Medical Devices
Senior Regulatory Affairs Program Lead (Software/OTTAVA)
- Santa Clara, CA
- Hybrid
- Full-time
- Senior & Principal
The role
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
You will be responsible for
· 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.
What you need
Qualifications / 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.
Preferred Qualificationsnice to have
· 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.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.
Preferred Skillsnice to have
AI Judgement Integration, Analytical Reasoning, Business Writing, Coaching, Collaboration, Communication, Legal Support, Problem Solving, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Regulatory Reporting, Risk Assessments, Strategic Thinking
Skills named in this posting
Pay and benefits
$112,000 – $208,150 a year
Employer providedThe anticipated base pay range for this position is
$112,000.00 - $180,550.00
For Bay Area:
$129,000.00 - $208,150.00
Retirement pension plan
401(k) savings plan
Vacation (120 hours per year)
Sick time
Holiday pay (13 days)
Parental leave
Where you'll work
Santa Clara, CAHybridOpen in Maps (opens in a new tab)
More jobs in Santa Clara, CAWorking conditions
Job Function
Regulatory Affairs Group
Job Sub Function
Regulatory Affairs
Job Category
Professional
All Job Posting Locations
Cincinnati, Ohio, United States of America, Remote (US), Santa Clara, California, United States of America
From the posting
About Johnson & Johnson
About Surgery
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
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.
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.
Equal opportunity, accessibility and legal noticesJohnson & Johnson's statements, word for word
Additional Description for Pay Transparency
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
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 period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Job intelligence
The context around this role
Live data · November 12, 2026
Salary intelligence
How the pay compares
This role's midpoint is 3% above the US median for Regulatory Strategy roles at this level.
This roleEmployer provided
Senior & Principal roles in the US8 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $112,000 | — | $208,150 |
| All US (middle half) | $150,000 | $155,000 | $171,250 |
This role: Johnson & Johnson's own published range. Comparisons: the base pay employers published on open Regulatory Strategy roles at the same level on Regulatory Jobs, November 12, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Strategy
The general path across 94 open Regulatory Strategy roles on Regulatory Jobs, with the titles they carry most. Not Johnson & Johnson's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 27 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Regulatory submissions7
- Collaboration and leadership7
- Documentation and SOPs5
- GMP and compliance4
- Data and digital systems3
- Lab testing and methods2
- Quality systems and risk2
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Regulatory Strategy work in medical devices, led by the six this posting names, each linked to the agency or standards body that publishes it.
- FDAFDA Q-Submission Program(official source, opens in a new tab)Pre-Submissions and meetings with FDA on device submissionsNamed in the posting
- FDAFDA De Novo(official source, opens in a new tab)Classification requests for novel low- to moderate-risk devicesNamed in the posting
- FDAFDA 510(k)(official source, opens in a new tab)Premarket notification: showing substantial equivalence to a legally marketed deviceNamed in the posting
- FDA21 CFR Part 812(official source, opens in a new tab)Investigational device exemptions for clinical studies of devicesNamed in the posting
- IECIEC 60601-1(official source, opens in a new tab)Basic safety and essential performance of medical electrical equipmentNamed in the posting
- ISOISO 10993-1(official source, opens in a new tab)Biological evaluation of medical devices within a risk management processNamed in the posting
- FDA21 CFR Part 814(official source, opens in a new tab)Premarket approval of class III medical devices
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devices
- FDAFDA cybersecurity in medical devices(official source, opens in a new tab)Quality system considerations and premarket content for device cybersecurity
- FDA21 CFR Part 56(official source, opens in a new tab)Institutional review boards for FDA-regulated clinical investigations
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilance
- EUEU IVDR (Regulation 2017/746)(official source, opens in a new tab)The EU In Vitro Diagnostic Medical Devices Regulation
- EUMDCG guidance(official source, opens in a new tab)The Medical Device Coordination Group's endorsed guidance on applying the MDR and IVDR
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices, aligned with ISO 13485
Company hiring pulse
Johnson & Johnson on Regulatory Jobs
- 42
- Open roles
- 42
- Distinct roles
- 17
- Locations
By discipline
- Quality25 60%
- Clinical9 21%
- Regulatory8 19%
By level
- Senior & Principal16 38%
- Manager15 36%
- Associate & Specialist6 14%
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Senior Regulatory Affairs Program Lead (Software/OTTAVA) at Johnson & Johnson
Applications close December 4. $112K–$208K a year, employer provided.