Senior Regulatory Affairs Program Lead (Software/OTTAVA)

Biopharma Asia; Santa Clara (CA); Hybrid; USD 129,000 - 208,000; Full time

Benefits offered by this job

Consolidated retirement plan (pension)

Sick time

Vacation

Holiday pay

Parental Leave

Bereavement Leave

Volunteer Leave

Military Spouse Time-Off

Job summary

Johnson & Johnson, Santa Clara, CA, seeks a Senior Regulatory Affairs Program Lead for the OTTAVA robotics group. The role leads regulatory strategy for NPD and LCM, and coordinates submissions, filings, and health authority interactions with engineering and clinical teams across the US and international markets.

Preference given to candidates near Santa Clara with remote options evaluated case-by-case. The role requires 6+ years in medical device regulatory affairs, including software-enabled

Qualifications

• Bachelor’s degree required; Advanced degree preferred.
• 6+ years regulatory affairs in medical devices including software-enabled.
• Proven track record of securing regulatory approvals (510(k), IDE, De Novo).
• Collaborative & flexible – comfortable navigating ambiguity.
• Excellent cross-functional communicator; able to influence within regulatory & across functions.
• Independent strategic thinker; synthesizes guidance & trends to drive regulatory strategy.
• Up to 10% travel.

Responsibilities

• Prepare and execute regulatory strategies for NPD and LCM projects.
• Lead regulatory strategy across product development, submission, approval, and LCM activities.
• Serve as regulatory SME on cross-functional teams for electromechanical devices with software-enabled functionality.
• Prepare, write and file FDA submissions (e.g., Q-submissions, IDEs, De Novo, 510(k)s); lead FDA meeting prep.
• Execute sustaining activities including change assessments, Letters To File, registrations and renewals.
• Support global health authorities’ submissions; apply guidance and standards to portfolio.
• Support audits and regulatory inspections.

Skills

Regulatory strategy

Cross-functional collaboration

FDA submissions

Regulatory leadership

Risk assessment

Regulatory intelligence

Education

Bachelor’s degree

Advanced degree preferred

Tools

FDA submission portals

Regulatory databases

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.

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

Job Description:

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 aSenior Regulatory Affairs Program Leadto 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.

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.

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 Qualifications

• 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 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.

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 Skills:

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

The anticipated base pay range for this position is :

$112,000.00 - $180,550.00

For Bay Area:

$129,000.00 - $208,150.00

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