New · posted Oct 20
Johnson & Johnson · Medical Devices
Regulatory Affairs Specialist I – Spine
- Raynham, MA
- Hybrid
- Full-time
- Associate & Specialist
Closes Oct 26, 2026 · 7 days left
The role
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.
Other
This position will be located in Raynham, MA, and may require up to 10% domestic and international travel.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
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.
For more information on how we support the whole health of our employees throughout their wellness, career, and life journey, please visit www.careers.jnj.com.
What you need
Education
- Minimum of a bachelor’s degree required, advanced degree strongly preferred. Desired fields of study include science, engineering (e.g., biomedical, electrical, software, mechanical), business, legal, or similar.
- Experience in a highly regulated industry preferred, preferably with medical devices. Relevant internship experience may be considered.
- Demonstrated intellectual capacity to identify, read, understand, and address global medical device regulations are required.
- Experience in the preparation and submission of US regulatory filings (e.g., 510(k), PMA) as well as European technical files and design dossiers is strongly preferred.
- Knowledge of US and European regulatory processes is preferred.
- Must have excellent written, verbal communication, and presentation skills.
What you'll do
- Provides regulatory guidance to product development teams in defining regulatory strategies, pre-marketing, and related submissions to support optimal timelines for new/modified product launches in the global market
- Execute on the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers, including, but not limited to 510(k) submissions, Pre-Submissions, HDEs, Change Notifications, Technical Documents, and correspondence with health authorities.
- Guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials.
- Defines data and information needed for regulatory marketing authorizations.
- Develops labeling specifications and approves proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations.
- Provide Regulatory Affairs support during internal and external audits.
- Plans schedules for delivery of supporting documentations required for regulatory submissions on a project and monitors project through completion.
- Assists in the development of improved and efficient processes practices for Regulatory Affairs processes.
- Represents Regulatory Affairs on cross-functional project teams, guiding and supporting product development teams on both US and international issues.
- Partners with other functions to define and generate data to assist with regulatory submissions.
- Review and provide regulatory authorization for changes to products, processes, and quality system procedures.
- Respond to requests from foreign governments and/or distributors to prepare and submit documentation for marketing approvals in other countries, as well as provide routine regulatory information to associates and affiliates.
Pay and benefits
$64,000 – $102,350 a year
Employer providedThe anticipated base pay range for this position is
$64,000.00 - $102,350.00
Retirement pension plan
401(k) savings plan
Long-term incentive program
Vacation (120 hours per year)
13days
13 days holiday pay
Parental leave
Where you'll work
Raynham, MAHybridOpen in Maps (opens in a new tab)
More jobs in Raynham, MAWorking conditions
Job Function
Regulatory Affairs Group
Job Sub Function
Regulatory Affairs
Job Category
Professional
All Job Posting Locations
Raynham, Massachusetts, 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
DePuy Synthes Companies of Johnson & Johnson is recruiting for a Regulatory Affairs Analyst – Spine, located on-site in Raynham, MA. This is a J&J Flex position with minimum three days of on-site work. There is no full-time remote option.
Equal opportunity, accessibility and legal noticesJohnson & Johnson's statements, word for word
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)).
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
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against based on disability.
Job intelligence
The context around this role
Live data · October 20, 2026
Salary intelligence
How the pay compares
This role's midpoint is 9% below the US median for Regulatory Affairs roles at this level.
This roleEmployer provided
Associate & Specialist roles in the US30 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $64,000 | — | $102,350 |
| All US (middle half) | $83,250 | $91,750 | $95,375 |
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 20, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 302 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 24 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Regulatory submissions7
- GMP and compliance4
- Documentation and SOPs4
- Collaboration and leadership3
- Quality systems and risk1
- 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.
- 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
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Johnson & Johnson on Regulatory Jobs
- 42
- Open roles
- 42
- Distinct roles
- 19
- Locations
By discipline
- Quality25 60%
- Regulatory13 31%
- Compliance & Safety4 10%
By level
- Senior & Principal13 31%
- Associate & Specialist13 31%
- Manager11 26%
More roles at Johnson & Johnson
- View role
Director, North America Regulatory Affairs Leader
Raritan, NJ +2 more · HybridDirectorPharmaceuticals$164K–$283K
- View role
Manager, Regulatory Affairs - Biomaterials
Raynham, MA +1 moreManagerMedical Devices$117K–$201K
- View role
Senior Regulatory Affairs Specialist (Wound Closure & Healing) - MedTech Surgery
Raritan, NJ · HybridSenior & PrincipalMedical Devices$92K–$148K
- View role
Senior Regulatory Affairs Program Lead (Wound Closure & Healing) - MedTech Surgery
Raritan, NJ +1 more · HybridSenior & PrincipalMedical Devices$109K–$175K
Similar Regulatory Affairs roles elsewhere
- View role
Regulatory Affairs Associate II
InBios InternationalSeattle, WAAssociate & SpecialistMedical Devices$92K–$125K
- View role
Regulatory Affairs Specialist II – Vascular
AbbottTemecula, CAAssociate & SpecialistMedical Devices$61K–$123K
- View role
Regulatory Specialist
Globus MedicalAudubon, PAAssociate & SpecialistMedical DevicesSalary not listed
- View role
Regulatory Associate
Globus MedicalAudubon, PAAssociate & SpecialistMedical DevicesSalary not listed
Regulatory Affairs Specialist I – Spine at Johnson & Johnson
Applications close October 26. $64K–$102K a year, employer provided.