Regulatory Affairs Specialist I – Spine

Johnson & Johnson • Raynham, MA

2d • Onsite

About The Position

DePuy Synthes Companies of Johnson & Johnson is recruiting a Regulatory Affairs professional to support its Spine business in Raynham, Massachusetts. The position is on-site under J&J Flex, requiring a minimum of three days on-site each week; a full-time remote option is not available. The role may require up to 10% domestic and international travel.

The position provides regulatory guidance to product development teams and supports regulatory strategies, product launches, marketing authorizations, and maintenance of existing products in the United States and international markets. It also supports compliance with applicable regulations across product development, claims, labeling, packaging, advertising, promotional materials, quality-system procedures, and audits. The role works with cross-functional teams and partners to plan and deliver submission materials, generate supporting data, and improve Regulatory Affairs processes.

Requirements

• Bachelor’s degree in a relevant field of study.
• Demonstrated ability to identify, read, understand, and address global medical device regulations.
• Excellent written and verbal communication and presentation skills.

Nice To Haves

• Advanced degree; strongly preferred.
• Study in science, engineering (such as biomedical, electrical, software, or mechanical), business, legal studies, or a similar field.
• Experience in a highly regulated industry, preferably medical devices; relevant internship experience may be considered.
• Experience preparing and submitting US regulatory filings such as 510(k)s or PMAs, as well as European technical files and design dossiers; strongly preferred.
• Knowledge of US and European regulatory processes.

Responsibilities

• Provide regulatory guidance to product development teams on regulatory strategies, pre-marketing activities, and submissions supporting timely global product launches.
• Execute submissions for licenses and authorizations, including maintenance of existing products, international registrations, and dossiers such as 510(k)s, Pre-Submissions, HDEs, Change Notifications, and Technical Documents.
• Guide conformance with applicable regulations in product development, claims support, content labeling, and promotional materials.
• Define data and information needed for regulatory marketing authorizations.
• Develop labeling specifications and approve proposed labeling, packaging, advertising, and promotional materials for regulatory conformance.
• Provide Regulatory Affairs support during internal and external audits.
• Plan schedules for supporting documentation required for regulatory submissions and monitor projects through completion.
• Assist in developing more efficient Regulatory Affairs processes and practices.
• Represent Regulatory Affairs on cross-functional project teams and guide product development teams on US and international issues.
• Partner with other functions to define and generate data for regulatory submissions.
• Review and provide regulatory authorization for changes to products, processes, and quality-system procedures.
• Respond to requests from foreign governments and distributors by preparing and submitting documentation for marketing approvals in other countries, and provide routine regulatory information to associates and affiliates.

Benefits

• Participation in the company’s consolidated retirement plan (pension) and savings plan (401(k)), subject to plan terms.
• Eligibility to participate in the long-term incentive program.
• Vacation: 120 hours per calendar year, subject to policy and hire date.
• Sick time: 40 hours per calendar year, with location-specific amounts for Colorado and Washington employees.
• 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, or foster care of a child.
• Bereavement leave: 240 hours for an immediate family member and 40 hours for an extended family member per calendar year.
• Caregiver leave: 80 hours in a 52-week rolling period.
• Volunteer leave: 32 hours per calendar year.
• Military spouse time off: 80 hours per calendar year.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level