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.
**Job Function: **
Regulatory Affairs Group
**Job Sub Function: **
Regulatory Affairs
Job Category:
Professional
All Job Posting Locations:
Irvine, California, United States of America, Milpitas, California, United States of America
Job Description:
About Vision
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 on the possibilities of vision treatments? Ready to join a team that’s reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs – from the pediatric to aging eye – in a patient’s lifetime.
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 Specialist. This role will work a Hybrid/Flex schedule with 3 days per week on-site and must be based within a commutable distance of Irvine, CA or Milpitas, CA.
Purpose: The Senior Regulatory Affairs Specialist provides regulatory support for product lifecycle activities, including modifications, re-registration, and labeling review. Responsible for developing regulatory strategies, ensuring compliance, and supporting audits with minimal supervision.
You will be responsible for:
- Provides strategic regulatory guidance throughout product lifecycle stages.
- Leads preparation and submission of licensing, registration, and approval dossiers.
- Coordinates complex regulatory activities, including post-market modifications.
- Ensures conformance of product labeling, claims, and promotional materials.
- Develops regulatory strategies and plans for new product development.
- Reviews and approves labeling, packaging, and promotional content.
- Supports audits and inspections to ensure compliance.
- Guides and trains junior team members on regulatory processes.
- Maintains and monitors regulatory compliance across markets.
- Liaises with health authorities during inspections and inquiries.
- Tracks regulatory developments and advises on impact.
- Participates in cross-functional project teams at a leadership level.
- May supervise work of contract resources or interns.
Note: Duties and responsibilities of individuals in this role may vary depending on their specific focus at a given time, and not all responsibilities always apply to every individual.
Qualifications / Requirements:
- Minimum of a Bachelor’s Degree is required, Scientific Discipline strongly preferred.
- At least 4+ years of relevant related experience within a regulated environment or equivalent experience in another relevant function such as Quality, Medical, Clinical, R&D.
- Demonstrated experience with Regulatory LCM and 510k assessments highly desired.
- Prior experience with Class II or Class III Medical Devices strongly preferred.
- Experience interacting directly with US FDA required, EU MDR experience preferred.
- Ability to effectively manage multiple projects and priorities.
- Strong communication and regulatory writing skills.
- Strong problem solving skills, interpersonal skills and effective team member.
- Results oriented. Ability to drive to completion in adherence to aggressive project schedules.
- Up to 10% travel may be required.
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.
#LI-Hybrid
Required Skills:
Preferred Skills:
510 (K), 510k Submission, EU MDD, FDA Medical Device Regulations, FDA Regulations, FDA Submissions, Regulatory Approvals, Regulatory Documents, Regulatory Filings, Regulatory Responses, Regulatory Submissions, Regulatory Writing
The anticipated base pay range for this position is :
The base pay range for this position is $92,000 to $148,350.
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. 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 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 Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits