Regulatory Affairs Specialist I – Spine

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

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Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Raynham, Massachusetts, United States of America

Job Description:

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

DePuy Synthes Companies of Johnson & Johnson is recruiting for a Regulatory Affairs Analyst – Spine, located on-site in Raynham, MA. This is a J&J Flex position with minimum three days of on-site work. There is no full-time remote option.

Key Responsibilities:

• Provides regulatory guidance to product development teams in defining regulatory strategies, pre-marketing, and related submissions to support optimal timelines for new/modified product launches in the global market
• Execute on the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers, including, but not limited to 510(k) submissions, Pre-Submissions, HDEs, Change Notifications, Technical Documents, and correspondence with health authorities.
• Guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials.
• Defines data and information needed for regulatory marketing authorizations.
• Develops labeling specifications and approves proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations.
• Provide Regulatory Affairs support during internal and external audits.
• Plans schedules for delivery of supporting documentations required for regulatory submissions on a project and monitors project through completion.
• Assists in the development of improved and efficient processes practices for Regulatory Affairs processes.
• Represents Regulatory Affairs on cross-functional project teams, guiding and supporting product development teams on both US and international issues.
• Partners with other functions to define and generate data to assist with regulatory submissions.
• Review and provide regulatory authorization for changes to products, processes, and quality system procedures.
• Respond to requests from foreign governments and/or distributors to prepare and submit documentation for marketing approvals in other countries, as well as provide routine regulatory information to associates and affiliates.

Qualifications

Education:

• Minimum of a bachelor’s degree required, advanced degree strongly preferred. Desired fields of study include science, engineering (e.g., biomedical, electrical, software, mechanical), business, legal, or similar.

Experience and Skills:

• Experience in a highly regulated industry preferred, preferably with medical devices. Relevant internship experience may be considered.
• Demonstrated intellectual capacity to identify, read, understand, and address global medical device regulations are required.
• Experience in the preparation and submission of US regulatory filings (e.g., 510(k), PMA) as well as European technical files and design dossiers is strongly preferred.
• Knowledge of US and European regulatory processes is preferred.
• Must have excellent written, verbal communication, and presentation skills.

Other:

This position will be located in Raynham, MA, and may require up to 10% domestic and international travel.

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

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