Senior Regulatory Affairs Program Lead (OTTAVA) - MedTech Surgery

6267-Auris Health Inc. Legal Entity

Santa Clara (CA)

Hybrid

USD 125,000 - 201,000

Full time

14 days+

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Job summary

Johnson & Johnson is seeking a Senior Regulatory Affairs Program Lead for the OTTAVA robotics group, ideally located near Santa Clara, CA, with remote options considered. You will drive regulatory strategy, author submissions such as FDA 510(k)s/IDE de novo filings, and collaborate with engineering and clinical teams to advance robotic systems.

Travel up to 10% may be required. Required: bachelor’s degree, 6+ years in regulatory affairs for medical devices including software-enabled systems, and

Qualifications

Minimum of a Bachelor’s degree; advanced degree preferred.
6+ years of regulatory affairs experience in medical devices including software-enabled systems.
Proven track record of securing regulatory approvals (e.g., 510(k)s, IDEs, De Novo).
Strong cross-functional collaboration and communication skills.
Willingness to travel up to 10%.

Responsibilities

Prepare and execute regulatory strategies for NPD and LCM projects.
Lead regulatory submissions and health authority communications for US and international markets.
Serve as regulatory SME for cross-functional teams on electromechanical devices with software-enabled functionality.
Support audits and regulatory registrations/renewals; maintain compliance with guidances and standards.

Skills

Regulatory affairs

Medical devices

Software-enabled devices

FDA submissions

Cross-functional collaboration

Travel willingness

Education

Bachelor's degree

Advanced degree preferred

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:

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 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.

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.

Required Skills:

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

Preferred Skills:

The anticipated base pay range for this position is :

$125,000.00 - $201,250.00

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

At Johnson & Johnson,we believe health is everything.

Our Credo calls on us to respect the dignity of every individual and create an environment for all people to thrive. Throughout the recruitment process - from application through hiring - we are committed to providing reasonable accommodations/adjustments for qualified candidates with disabilities. If you need support at any stage of the recruitment process, please complete our candidate accommodation request form so we can assist you.

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