Senior Regulatory Affairs Program Lead

Johnson & Johnson•Irvine, CA

3d•Remote

About The Position

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. About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech 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 https://www.jnj.com/ . Remote work options may be considered on a case-by-case basis and if approved by the Company. An internal pre-identified candidate for consideration has been identified. However, all applications will be considered. We are searching for the best talent for Senior Regulatory Affairs Program Lead Job summary Under minimal supervision, the Senior Regulatory Affairs Program Lead provides strategic, end‑to‑end regulatory leadership for complex Class III medical device programs, with primary accountability for US PMA pathways, global market access, and lifecycle sustainability . This role serves as a regulatory subject matter expert and program lead , partnering with R&D, Clinical, Quality, Manufacturing, and regional affiliates to define and execute regulatory strategies that protect commercialization timelines and enable global growth. The position is expected to independently lead high‑risk submissions , direct regulatory interactions with Health Authorities , and global audit readiness , while influencing cross‑functional decision‑making and mentoring less‑experienced regulatory professionals.

Requirements

Bachelor’s degree in engineering, life sciences, or related discipline required
Minimum 4 years of progressive experience in Medical Device Regulatory Affairs, including direct responsibility for US and EU Class III medical device submissions and technical documentation, with proven ability to develop and execute strategies for new product development projects, and maintain existing products through the assessment of regulatory impact of changes. This includes experience documenting rationales for all required actions.
Given the focus of the business unit, hands-on experience with neurovascular devices is required; experience with peripheral and coronary vascular devices is beneficial for broader portfolio support.
In addition, direct experience with liquid embolic device technologies, including the preparation of written communications and technical documentation for regulatory authorities is a critical requirement.
To meet the responsibilities of the role and work with internal and external stakeholders, strong written and oral communication skills, with a proven ability to collaborate effectively with R&D, Clinical, Commercial, and Supply Chain teams throughout the product development process to market launch are required skills.
A minimum of 3 years of direct communication with FDA and Notified Bodies via email, phone, and in-person meetings, including preparation and defense of IDE, PMA, and Q-Sub submissions, responses to FDA questions and Additional Information (AI) requests, and participation in both in-person and virtual FDA meetings.
Experience supporting global submissions and regulatory maintenance activities for Health Canada, China NMPA, Japan PMDA, EU MDR, UK, and Australia (TGA/ARTG), including collaboration with local regulatory leads and preparation of required documentation and responses to information requests.
Demonstrated experience leading or supporting MDSAP audits as a Regulatory SME, with preference for candidates who have served as audit backroom facilitators across multiple jurisdictions.
The preferred candidate must be Fluent in English.

Nice To Haves

Advanced degree (MS, PhD) preferred
Experience with 510(k) and HDE submissions is strongly preferred and will be considered an asset for supporting the broader device portfolio.
The ability to speak at least one Asian language (e.g., Mandarin, Hindi, Japanese, Korean) is strongly preferred.

Responsibilities

Regulatory Strategy & Program Leadership Lead the development and execution of regulatory strategies for US and EU Class III neurovascular medical devices, with a focus on liquid embolic technologies.
Act as the Regulatory Program Lead for new product development, indication expansions, and complex lifecycle changes, ensuring alignment at critical program decision points.
Independently assess regulatory risk, define mitigation strategies, and drive cross-functional alignment.
US & Global Submissions Lead and author US PMA submissions—including Panel-Track PMA Supplements, IDE supplements, Q-Submissions, and Annual Reports—while coordinating with cross-functional teams to ensure timely and high-quality submissions.
Support and coordinate Health Canada submissions for Class III and IV devices, including full licenses and Special Access Program (SAP) applications.
Lead or contribute to China (NMPA) and Japan (PMDA) submissions, collaborating with regional affiliates and local agents.
Support regulatory registrations and maintenance activities in the EU (MDR), UK, Australia (TGA), and other global markets.
EU MDR & International Regulatory Compliance Lead the preparation, maintenance, and defense of EU MDR Technical Documentation for Class III devices, ensuring compliance with GSPR, clinical evidence, labeling, and declarations of conformity.
Ensure alignment with Australian regulatory documentation requirements, including ARTG technical documentation and change notifications.
Serve as a regulatory liaison with Notified Bodies, supporting conformity assessments, surveillance, and change management activities.
Health Authority & Notified Body Engagement Communicate directly with FDA and Notified Bodies through written correspondence, teleconferences, and in-person meetings.
Represent Regulatory Affairs during FDA meetings (Pre-Sub, Day-100, Interactive Review) and Notified Body audits, preparing and defending responses to regulatory questions and deficiencies.
Audit & Quality System Support Serve as a Regulatory SME and backroom facilitator for MDSAP audits, leveraging over three years of experience supporting audits across multiple jurisdictions.
Provide Regulatory Affairs support during internal and external audits, inspections, and management reviews, partnering with Quality to address observations, nonconformances, and CAPAs related to regulatory processes.
Regulatory Operations & Systems Lead regulatory documentation activities within the Windchill PLM environment, managing regulatory data, change control, and submission-related documentation with over four years of experience.
Ensure accurate and compliant documentation within regulatory databases and PLM systems to support global submissions and audits.
Contribute to the continuous improvement of regulatory processes, templates, and best practices.
Leadership & Collaboration Act as a senior Regulatory Affairs representative on cross-functional core teams, providing technical review and mentoring support to junior regulatory staff.
Build strong partnerships with regional affiliates to enable efficient global execution.

Benefits

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)).
This position is eligible to participate in the Company’s long-term incentive program.
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