Senior Regulatory Affairs Program Lead (Software/OTTAVA)

6267-Auris Health Inc. Legal Entity; Santa Clara (CA); Remote; USD 112,000 - 181,000; Full time

Job summary

Johnson & Johnson is seeking a Senior Regulatory Affairs Program Lead to drive regulatory strategies for the OTTAVA robotics portfolio. You will collaborate with engineering and clinical teams to develop submissions, manage health authority communications, and help achieve US and international approvals.

The role involves leading multiple projects with complex details, ensuring compliance with FDA guidelines and international standards, and supporting audits and registrations.

Qualifications

• Bachelor’s degree required; advanced degree preferred.
• 6+ years regulatory affairs in medical devices including software-enabled systems.
• Proven track record securing regulatory approvals (510(k), IDEs, De Novo).
• Strong collaboration and communication across functions.
• Experience US market/regulatory submissions and health authorities.
• Willingness to travel up to 10%.

Responsibilities

• Prepare and execute regulatory strategies for NPD and LCM projects.
• Serve as strategic regulatory lead across development, submission, approval, and LCM activities.
• Regulatory SME on cross-functional teams with knowledge of electromechanical devices with software.
• Review and provide regulatory feedback for specs, testing, risk, labeling and docs for submissions.
• Prepare and file FDA submissions (Q-submissions, IDEs, De Novo, 510(k)).
• Lead FDA meeting preparation.
• Support audits and global health authority submissions.
• Apply knowledge of guidances, regs, and standards relevant to portfolio.

Skills

Regulatory strategy

FDA submissions

Medical devices

Software-enabled

Cross-functional comms

Education

Bachelor's degree

Advanced degree

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 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.

Equal Opportunity Statement

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.

Veteran and Disability Inclusion

We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Accommodation and Interview Process

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

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

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 period
• 10 days Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

Salary

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 Company Information

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 https://www.jnj.com/.

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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