New · posted Oct 14
Johnson & Johnson · Medical Devices
Senior Regulatory Affairs Specialist
- Warsaw, IN +2 more
- On-site
- Full-time
- Senior & Principal
Closes Oct 25, 2026 · 12 days left
The role
The Senior Regulatory Affairs Specialist is responsible for regulatory activities to support new, modified and currently marketed medical devices in the DePuy Joint Reconstruction portfolio. This includes the preparation of regulatory documentation for submission to regulatory authorities (e.g., IDE, 510(k), PMA, Design Dossiers, and Technical Documentation) or internal regulatory assessment documentation. The Regulatory Project Leader is also responsible for the review and approval of all device labeling and product support information used in the promotion and educational activities of DePuy Synthes products for compliance to global regulations and company policies and procedures. In conjunction with other functions they support post market and provide lead external and Internal audits.
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.
You will be responsible for
- Prepares regulatory documentation for DePuy devices, including IDE, 510(k), PMA, Technical Files, Design Dossier, and Technical Documentation files for submission to regional Health authorities per FDA, MDD and MDR requirements. This includes the resolution of regulatory issues and questions from regulatory agencies during the pre-market product development phase.
- Provides support in preparation, writing and submission of global registration activities (Japan, China, Australia, NZ) requirements.
- Incumbent knows, understands, incorporates and follows all applicable laws and regulations relating to DePuy Synthes business activities and Policies and Procedures of the Health Care Compliance Program and Code of Conduct.
- Guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials.
- Review and approve changes with Product Lifecycle Management System to devices, design, packaging and labelling for Notified Body, FDA, and Global impact
- Review product labeling and product support information for currently marketed products to ensure that product information and claims are consistent with premarket clearances and approvals and in compliance with relevant regulations and guidance.
- Maintain current knowledge to ensure compliance to the applicable regulatory and corporate standards/requirements (FDA Quality System Regulations, European Quality Standards and presiding Medical Device Regulation, ISO 13485, previous MDD, etc.).
- Perform other duties as assigned.
We are searching for the best talent for Senior Regulatory Affairs Specialist in Warsaw, IN, West Chester, PA , Raynham, MA.
What you need
Educational requirements
BA/BS Degree required; advanced degree or equivalent work experience preferred
Johnson and 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 email the Employee Health Support Center ([email protected]) or contact AskGS to be directed to your accommodation resource.
Qualifications / Requirements
- Minimum of 2 years plus prior relevant regulatory affairs or experience in medical devices, preferred
- A minimum of 2 years plus medical device industry experience or relevant medical device experience
- Knowledge or Familiarity of U.S. FDA and EU Medical Device Regulations MDR (and previous MDD) and presiding guidance’s and standards a plus
- Knowledge of orthopedic implants a plus
- Familiarity with electronic submission preparation a plus
- Excellent written and oral communication skills
- Ability to handle multiple tasks, self-motivate and be detail oriented
Preferred Skillsnice to have
Analytical Reasoning, Brand Research, Business Behavior, Design Thinking, Detail-Oriented, Industry Analysis, Market Research, Package and Labeling Regulations, Problem Solving, Process Oriented, Product Packaging Design, Project Management, Project Support, Proof Reading Software, Quality Assurance (QA), Regulatory Affairs Management, Regulatory Compliance, Risk Assessments, Safety-Oriented
Pay
$79,000 – $127,650 a year
Employer providedThe anticipated base pay range for this position is
$79,000.00 - $127,650.00
Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.
Where you'll work
Warsaw, IN +2 moreOn-siteOpen in Maps (opens in a new tab)
Also posted for: West Chester, PA · Raynham, MA
More jobs in Warsaw, IN +2 moreWorking conditions
Job Function
Regulatory Affairs Group
Job Sub Function
Regulatory Product Submissions and Registration
Job Category
Professional
All Job Posting Locations
Raynham, Massachusetts, United States of America, Warsaw, Indiana, United States of America, West Chester, Pennsylvania, United States of America
From the posting
About Johnson & Johnson
About Orthopaedics
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 Orthopaedics? Ready to join a team that’s reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems.
Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals.
Equal opportunity, accessibility and legal noticesJohnson & Johnson's statements, word for word
Additional Description for Pay Transparency
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
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.
Job intelligence
The context around this role
Live data · October 14, 2026
Salary intelligence
How the pay compares
This role's midpoint is 26% below the US median for Regulatory Affairs roles at this level.
This roleEmployer provided
Senior & Principal roles in the US45 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $79,000 | — | $127,650 |
| All US (middle half) | $117,000 | $139,500 | $150,000 |
This role: Johnson & Johnson's own published range. Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, October 14, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 201 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not Johnson & Johnson's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 22 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Regulatory submissions8
- GMP and compliance7
- Documentation and SOPs4
- Quality systems and risk2
- Collaboration and leadership2
- Lab testing and methods1
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices
- European UnionEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- FDAFDA 510(k)(official source, opens in a new tab)Premarket notification for medical devices
- FDAFDA PMA(official source, opens in a new tab)Premarket approval for class III medical devices
- FDAFDA OPDP(official source, opens in a new tab)The Office of Prescription Drug Promotion, which reviews advertising and promotion
Company hiring pulse
Johnson & Johnson on Regulatory Jobs
- 36
- Open roles
- 36
- Distinct roles
- 15
- Locations
By discipline
- Quality24 67%
- Regulatory7 19%
- Compliance & Safety5 14%
By level
- Senior & Principal11 31%
- Manager9 25%
- Director8 22%
More roles at Johnson & Johnson
- View role
Regulatory Affairs Specialist II
Warsaw, IN +4 moreAssociate & SpecialistMedical Devices$76K–$122K
- View role
Senior Manager, North America Regulatory Liaison
Spring House, PA +2 more · HybridManagerPharmaceuticals$137K–$236K
- View role
Director, Regulatory Affairs
Raynham, MA +3 moreDirectorMedical Devices$164K–$283K
- View role
Senior Regulatory Affairs Program Lead (OTTAVA) - MedTech Surgery
Santa Clara, CA · HybridSenior & PrincipalMedical Devices$125K–$201K
Similar Regulatory Affairs roles elsewhere
- View role
Principal Regulatory Affairs Specialist
Cardinal HealthRemote, USSenior & PrincipalMedical Devices$81K–$127K
- View role
Sr. Regulatory Affairs Specialist - Recall and Post-Market Compliance
IlluminaUnited States · HybridSenior & PrincipalMedical Devices$90K–$135K
- View role
Principal Regulatory Affairs
MedlineRemote, IllinoisSenior & PrincipalMedical Devices$116K–$174K
- View role
Staff Regulatory Affairs Specialist - Pharma
Becton DickinsonVernon Hills, ILSenior & PrincipalMedical Devices$118K–$189K
Senior Regulatory Affairs Specialist at Johnson & Johnson
Applications close October 25. $79K–$128K a year, employer provided.