Regulatory Affairs Specialist I – Spine (Medical Devices)

Location: Raynham, Massachusetts, United States; hybrid with a minimum of three days on-site and no full-time remote option. Up to 10% domestic and international travel may be required.

Salary: $64,000–$102,350 per year

Company

Johnson & Johnson MedTech develops healthcare and orthopaedic solutions, including products for spine care, joint reconstruction, trauma, robotics, and digital surgery.

What you will do

• Provide regulatory guidance for product development, regulatory strategies, pre-market activities, and product launches.
• Prepare and submit licenses, authorizations, international registrations, 510(k) submissions, Pre-Submissions, HDEs, change notifications, and technical documentation.
• Evaluate and approve labeling, packaging, advertising, promotional materials, product changes, processes, and quality system procedures for regulatory compliance.
• Define submission data requirements, coordinate supporting documentation, and monitor projects through completion.
• Represent Regulatory Affairs on cross-functional teams and support internal and external audits.
• Respond to foreign government and distributor requests and provide regulatory information to associates and affiliates.

Requirements

• Bachelor’s degree required; an advanced degree is strongly preferred in science, engineering, business, legal studies, or a related field.
• Ability to identify, understand, and address global medical device regulations.
• Experience in a highly regulated industry, preferably medical devices; relevant internship experience may be considered.
• Excellent written, verbal communication, and presentation skills.
• Experience with US regulatory filings such as 510(k) and PMA, European technical files, and design dossiers is strongly preferred.
• Availability to work on-site in Raynham at least three days per week.

Nice to have

• Knowledge of US and European regulatory processes.
• Experience preparing and submitting US and European medical device regulatory documentation.

Culture & Benefits

• Inclusive work environment guided by the company’s Credo and focused on healthcare innovation.
• Participation in pension, 401(k), and long-term incentive plans, subject to applicable plan terms.
• Paid vacation, sick time, holidays, personal and family time, parental leave, bereavement leave, caregiver leave, volunteer leave, and military spouse time-off.
• Reasonable accommodations are available for qualified individuals with disabilities.