New · posted Oct 19
Johnson & Johnson · Medical Devices
Manager, Regulatory Affairs - Biomaterials
- Raynham, MA +1 more
- On-site
- Full-time
- Manager
Closes Oct 23, 2026 · 4 days left
The role
The Manager, Regulatory Affairs – Biomaterials External Innovation is responsible for developing and executing regulatory strategies for biomaterials, biologics, combination products, and externally sourced innovation opportunities. In partnership with cross-functional teams and external partners, this role provides early-stage regulatory guidance, supports due diligence and business development activities, and advances product development, clinical programs, submissions, approvals, launch readiness, and lifecycle management. The Manager will provide specialized expertise in Chemistry, Manufacturing, and Controls (CMC), Current Good Manufacturing Practice (CGMP), Biologics License Applications (BLA), and Investigational Device Exemptions (IDE) to support timely, compliant decision-making and commercialization in key markets.
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.
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
We are searching for the best talent for a Manager, Regulatory Affairs – Biomaterials External Innovation to join our Orthopaedics team located in West Chester, PA or Raynham, MA.
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. 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.
What you need
Required Skills
Chemistry, Manufacturing, and Controls (CMC); Current Good Manufacturing Practice (CGMP); biologics and combination-product regulatory strategy; Biologics License Applications (BLA); Investigational Device Exemptions (IDE); regulatory submissions; early-stage regulatory strategy; external innovation assessment; regulatory due diligence; cross-functional collaboration; and clear written and verbal communication.
Qualifications & Experience
- Minimum of a bachelor’s degree in a scientific, engineering, pharmacy, or other relevant technical discipline is required. An advanced degree is preferred.
- Minimum of 8 years of relevant experience in the medical device, biologics, pharmaceutical, combination-product, or other regulated healthcare industry is required, including demonstrated experience supporting complex product development programs.
- Demonstrated specialized regulatory expertise in CMC and CGMP requirements is required; direct experience with BLA and IDE development, submission, or lifecycle support is strongly preferred.
- Demonstrated experience developing and executing regulatory strategies that align with business objectives is required. Experience assessing early-stage external innovation, conducting regulatory due diligence, and supporting external partnerships or business development opportunities is strongly preferred.
Preferred Skillsnice to have
Biomaterials, regenerative medicine, external partnerships, business development, global regulatory strategy, PMA, De Novo, 510(k), technical documentation, compliance risk, fact-based decision-making, continuous improvement, developing others, inclusive leadership, innovation, and strategic thinking.
On October 14, 2025, Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. 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.
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.
Preferred Skillsnice to have
Business Writing, Compliance Risk, Developing Others, Fact-Based Decision Making, Inclusive Leadership, Industry Analysis, Innovation, Leadership, Legal Support, Operations Management, Policy Development, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Strategic Thinking, Team Management
Functional, Leadership, and Technical Competencies
· Connect by cultivating external relationships with regulators in key markets (in partnership with Regions, Policy and EU Strategy leads) and internally collaborating with the R&D, Med Affairs, Clinical Affairs, GSM and other partners.
· Shape by anticipating and influencing regulatory changes in key markets to maximize patient access to innovative technologies.
- Leads through influence by providing clear direction, technical expertise, and constructive feedback to regulatory colleagues, project teams, and external partners.
- Delivers results by coordinating accountable cross-functional teams and external partners to achieve timely, high-quality regulatory outcomes while balancing strategic and near-term priorities.
· Strategic thinking and ability to partner and Influence key stakeholders at senior levels.
- Applies specialized scientific and regulatory expertise in biologics, biomaterials, combination products, CMC, CGMP, BLA, and IDE requirements to guide development planning, risk mitigation, submissions, and lifecycle activities in applicable markets.
- Promotes innovative thinking, informed risk-taking, intellectual curiosity, and continuous learning related to scientific, technological, manufacturing, clinical, and regulatory developments.
· Leverages expertise to educate and coach others on the development and execution of business plans and Regulatory Affairs strategies with a focus on innovative results.
· Advises and challenges others, including cross-functional business partners, to ensure the best business-level best decisions are consistently made within the organization and based on the Credo. Makes and stands behind complex and difficult decisions in ambiguous situations with a large potential impact on the organization.
What you'll do
Responsibilities include
In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
- Leads regulatory activities supporting the development, submission, approval, and lifecycle management of biomaterials, biologics, combination products, and medical devices before global regulatory authorities. Develops risk-based regulatory strategies to enable timely development and commercialization.
- Manages assigned Regulatory Affairs activities, establishes strategic priorities, and communicates regulatory objectives, risks, and recommendations to project teams and business leaders.
- Leads the preparation and maintenance of regulatory submissions and files, including BLAs, IDEs and IDE Supplements, PMAs and PMA Supplements, 510(k)s, De Novo requests, HDEs, annual reports, global change notifications, and technical documentation, as applicable to the assigned portfolio.
- Defines and executes regulatory strategies for pipeline development, clinical programs, and global launch readiness, with particular emphasis on Biomaterials External Innovation opportunities.
- Partners with R&D, Quality, Clinical, Medical Affairs, Supply Chain, Commercial, Business Development, and other cross-functional stakeholders to evaluate opportunities and implement regulatory strategies.
- Exercises independent judgment on complex regulatory issues, identifies key risks and evidence requirements, and drives execution of regulatory deliverables across assigned projects and external partnerships.
- Provides day-to-day leadership, coaching, and technical guidance to Regulatory Affairs colleagues and cross-functional project teams, as applicable.
- Develops and delivers training for cross-functional partners on current and emerging regulatory, CMC, CGMP, biologics, combination-product, and clinical investigation requirements.
· Responsible for ensuring aligned and coordinated contact and communication with global and regional/local regulatory agencies
· Ensures that company policies, procedures and practices are in compliance with appropriate regulatory requirements
- Supports timely regulatory approvals and clearances for assigned programs and contributes to capability planning by identifying gaps, proposing solutions, and implementing plans aligned with organizational and Regulatory Affairs objectives.
- Communicates a clear regulatory vision and fosters accountability, collaboration, and effective execution across internal teams and external partners.
- Leads Regulatory Affairs screening and technical due diligence for Biomaterials External Innovation, external partnerships, licensing, acquisition, and other business development opportunities; develops early-stage regulatory assessments, identifies critical risks and evidence needs, and recommends viable development pathways.
- Represents the Biomaterials External Innovation regulatory perspective in internal governance forums, partner interactions, diligence activities, and regulatory agency engagements.
Pay
$117,000 – $201,250 a year
Employer providedThe anticipated base pay range for this position is
$117,000.00 - $201,250.00
It is anticipated following conclusion of the transaction, you would be an employee of DePuy Synthes, and your employment would be governed by Orthopaedics employment processes, programs, policies, and benefit plans. Details of any planned changes would be provided to you by Orthopaedics at an appropriate time and subject to any necessary consultation processes.
Where you'll work
Raynham, MA +1 moreOn-siteOpen in Maps (opens in a new tab)
Also posted for: West Chester, PA
More jobs in Raynham, MA +1 moreWorking conditions
Job Function
Regulatory Affairs Group
Job Sub Function
Regulatory Affairs
Job Category
People Leader
All Job Posting Locations
Raynham, Massachusetts, United States of America, West Chester, Pennsylvania, United States of America
From the posting
About Johnson & Johnson
About Orthopaedics
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.
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
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 20, 2026
Salary intelligence
How the pay compares
This role's midpoint is 2% below the US median for Regulatory Affairs roles at this level.
This roleEmployer provided
Manager roles in Massachusetts6 roles publishing pay
Manager roles in the US49 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $117,000 | — | $201,250 |
| Massachusetts (middle half) | $138,750 | $150,000 | $166,875 |
| All US (middle half) | $147,500 | $162,500 | $175,000 |
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 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 41 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership21
- GMP and compliance9
- Regulatory submissions8
- Documentation and SOPs5
- Investigations and CAPA3
- Quality systems and risk1
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
- 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 De Novo(official source, opens in a new tab)Classification requests for novel low- to moderate-risk devices
- FDAFDA BLA(official source, opens in a new tab)Biologics License Applications
Company 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%
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Manager, Regulatory Affairs - Biomaterials at Johnson & Johnson
Applications close October 23. $117K–$201K a year, employer provided.