Regulatory Affairs Analyst

Johnson & Johnson Innovative Medicine•Raynham, MA

1d•Hybrid

About The Position

At Johnson & Johnson, health is everything. This role is for a Regulatory Affairs Analyst – Spine within the DePuy Synthes Companies, located on-site in Raynham, MA. It is a J&J Flex position requiring a minimum of three days of on-site work, with no full-time remote option. The Orthopaedics team focuses on developing smarter, less invasive, and more personalized treatments, helping over 6 million people move each year. The analyst will provide regulatory guidance to product development teams, execute submissions for new and modified products, maintain existing product licenses, ensure compliance with regulations, define data for marketing authorizations, develop and approve labeling and promotional materials, support internal and external audits, manage submission schedules, contribute to process improvements, represent Regulatory Affairs on cross-functional teams, and collaborate with other functions to generate data for submissions. The role also involves reviewing and authorizing changes to products, processes, and quality system procedures, and responding to requests from foreign governments for marketing approvals.

Requirements

Minimum of a bachelor’s degree required
Demonstrated intellectual capacity to identify, read, understand, and address global medical device regulations are required
Excellent written, verbal communication, and presentation skills

Nice To Haves

Advanced degree strongly preferred (Desired fields of study include science, engineering (e.g., biomedical, electrical, software, mechanical), business, legal, or similar)
Experience in a highly regulated industry preferred, preferably with medical devices
Relevant internship experience may be considered
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
Biomedical Technologies
Regulatory Requirements
Regulatory Submissions

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

Benefits

Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
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/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 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