Job Title
Regulatory Affairs Specialist II (Spine) - MedTech Orthopaedics
Company
Johnson & Johnson
Location
Raynham, Massachusetts, United States of America
Work Pattern
Hybrid Work (3 days in office per week; no remote option)
Job Category
Professional | Analyst, Regulatory Affairs (P4 – E24)
Job Function
Regulatory Affairs Group
Sub Function
Regulatory Affairs
Job Posting Details
Date Posted: August 29, 2025
Requisition Number: R-030767
Application Deadline: September 12, 2025 (may be extended)
Apply at: www.careers.jnj.com
Company Overview
Johnson & Johnson is committed to healthcare innovation, aiming to prevent, treat, and cure complex diseases with smarter, less invasive, and personalized treatments. The company integrates expertise in Innovative Medicine and MedTech to impact global health positively.
Learn more: https://www.jnj.com
Position Summary
Seeking a Regulatory Affairs Specialist II to support the Spine group. This role involves working closely with product development teams on regulatory strategies, submissions, and maintaining compliance for medical devices in the global market.
Key Responsibilities
Provide regulatory guidance to product development teams on strategy, submissions, and timelines for new/modified product launches globally.
Execute regulatory submissions and maintenance activities (e.g., 510(k), Pre-Submissions, HDEs, Change Notifications).
Serve as a Regulatory Affairs expert in product development and engineering design control teams, reviewing specifications, testing, risk management, and documentation.
Ensure compliance with applicable regulations related to product development, claims, labeling, and promotional materials.
Define data requirements for regulatory approvals.
Develop and approve labeling, packaging, advertising, and promotional materials for regulatory compliance.
Support internal and external audits with Regulatory Affairs expertise.
Plan and monitor regulatory submission documentation schedules.
Develop process improvements within Regulatory Affairs.
Represent Regulatory Affairs in cross-functional teams for US and international regulatory issues.
Collaborate with other departments to gather data supporting submissions.
Review and approve Engineering Change Orders (ECOs).
Respond to foreign government and distributor requests for marketing approval documentation.
Qualifications / Requirements
Bachelor’s Degree required; Advanced Degree strongly preferred. Fields include science, engineering (biomedical, electrical, software, mechanical), business, legal, or related.
Minimum 2+ years of professional regulatory experience (medical device or pharmaceutical preferred; 1+ year if advanced degree).
Strong ability to understand and apply global medical device regulations.
Experience with US regulatory filings (510(k), PMA) and European technical documentation preferred.
Knowledge of US and European regulatory processes preferred.
Excellent written and verbal communication, collaboration, and attention to detail.
High organizational skills with ability to manage multiple projects and prioritize effectively.
Strong learning and presentation skills for complex regulatory strategies.
Up to 10% travel may be required.
Compensation
Base Pay Range: $74,000 to $119,600 (anticipated)
Benefits
Medical, dental, vision, life insurance, short- and long-term disability
Business accident insurance, group legal insurance
Retirement plans (pension, 401(k))
Paid time off:
Vacation: 120 hours/year
Sick time: 40 hours/year (56 hours/year for Washington State residents)
Holidays: 13 days/year (including floating holidays)
Work, Personal and Family Time: up to 40 hours/year
Parental Leave: 480 hours within 1 year of birth/adoption/foster care
Condolence Leave: 30 days immediate family, 5 days extended family
Caregiver Leave: 10 days
Volunteer Leave: 4 days
Military Spouse Time-Off: 80 hours
More info: Employee Benefits
Equal Opportunity Employer
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, veteran status, or other protected characteristics.
The company actively seeks qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Accommodation Information
Johnson & Johnson is committed to an inclusive interview process. Applicants with disabilities needing accommodations can contact:
AskGS for accommodation resources
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