Regulatory Affairs Specialist II (Spine) - MedTech Orthopaedics

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 https://www.jnj.com

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:

We are searching for the best talent for a Regulatory Affairs Specialist II to support our Spine group.  This role will be based in our Raynham, MA office and will work a Flex/Hybrid schedule with 3 days per week in office.  There is NO remote option.

You will be responsible for:


* 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 Notified Bodies.


* Serves as a Regulatory Affairs subject matter expert on new product development and engineering design control teams.

This includes conducting reviews and providing expert regulatory feedback for specifications, device testing, risk management, and other relevant documentation in accordance with regulatory requirements and with positioning for regulatory submission.


* 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, including Purchased for Resale products.


* Partners with other functions to define and generate data to assist with regulatory submissions.


* Review and provide regulato...