Regulatory Affairs Specialist I

DePuy Synthes, part of Johnson & Johnson MedTech, is recruiting for a
Regulatory Affairs Specialist I to support our Spine business.

This role is located on-site in Raynham, MA and will work a Flex/Hybrid schedule with three days of on-site and two days of off-site work .

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.

• Provides independent 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
• Leads the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers, including, but not limited to 510(k) submissions, IDE/IDE Supplements, PMA/PMA Supplements, Annual Reports, HDEs, IND/NDA Supplements, Design Dossiers/Change Notifications, and Technical Files.
• Guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials.
• Defines data and information needed for regulatory approvals.
• 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 Engineering Change Orders (ECOs).
• 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.