Manager, Regulatory Affairs- Biomaterials

6029-MEDICAL DEVICE BUSINESS SERVICES, INC. Legal Entity; Raynham (MA); Presencial; USD 117 000 - 201 000; Tempo integral

Resumo da oferta

Johnson & Johnson is seeking a Manager, Regulatory Affairs – Biomaterials External Innovation to lead regulatory strategies for biomaterials and externally sourced innovation opportunities within Orthopaedics. The role focuses on CMC/CGMP expertise to support development, submissions, and lifecycle management in global markets.

You will partner with R&D, Quality, Clinical, and Business Development, guiding early-stage assessments and due diligence for external partnerships.

Qualificações

• Minimum bachelor’s degree in a scientific/engineering field is required.
• Minimum 8 years of relevant regulatory experience in medical devices/biologics/pharma.
• Experience with BLA and IDE development, submissions, and lifecycle support preferred.

Responsabilidades

• Lead regulatory activities for biomaterials, biologics, and combination products.
• Develop and execute regulatory strategies for pipeline development and global launches.
• Prepare and maintain regulatory submissions (BLAs, IDEs, PMAs, 510(k)s) and related documentation.
• Collaborate with R&D, Quality, Clinical, Medical Affairs, and other functions.

Conhecimentos

Regulatory leadership

Regulatory strategy

CMC/CGMP knowledge

BLA/IDE submissions

Due diligence

Cross-functional collaboration

Regulatory communications

Coaching/mentoring

Formação académica

Bachelor’s degree in science/engineering/pharmacy

Advanced degree preferred

Descrição da oferta de emprego

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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: People Leader. All Job Posting Locations: Raynham, Massachusetts, United States of America, West Chester, Pennsylvania, United States of America.

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.

Purpose: 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.

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 agent engagements.

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.
• Advise 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.
• Make and stand behind complex and difficult decisions in ambiguous situations with a large potential impact on the organization.

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.

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. 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.

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.

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.

Preferred Skills:

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.

The anticipated base pay range for this position is : $117,000.00 - $201,250.00

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

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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/.