Regulatory Affairs Specialist I – Spine

DePuy Synthes Companies of Johnson & Johnson is hiring a Regulatory Affairs professional for its Spine business. The role supports global regulatory strategies and submissions, product development and lifecycle compliance, labeling, audits, and cross-functional teams.

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

Preferred

• 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
• Advanced degree
• Science
• Legal
• Regulated industry experience
• Medical device experience
• Relevant internship experience
• US regulatory filing preparation
• US regulatory filing submission
• 510(k) filings
• PMA filings
• European technical files
• Design dossiers
• US regulatory processes
• European regulatory processes

Benefits

• Eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)), subject to the terms of their respective plans.
• Eligible to participate in the Company’s long-term incentive program.
• Vacation – 120 hours per calendar year, subject to the terms of the respective policies and date of hire.
• Sick time – 40 hours per calendar year; 48 hours per calendar year for employees who reside in Colorado; 56 hours per calendar year for employees who reside in Washington, subject to the terms of the respective policies and date of hire.
• Holiday pay, including Floating Holidays – 13 days per calendar year, subject to the terms of the respective policies and date of hire.
• Work, Personal and Family Time – up to 40 hours per calendar year, subject to the terms of the respective policies and date of hire.
• Parental Leave – 480 hours within one year of the birth, adoption, or foster care of a child, subject to the terms of the respective policies and date of hire.
• Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year, subject to the terms of the respective policies and date of hire.
• Caregiver Leave – 80 hours in a 52-week rolling period, subject to the terms of the respective policies and date of hire.
• Volunteer Leave – 32 hours per calendar year, subject to the terms of the respective policies and date of hire.
• Military Spouse Time-Off – 80 hours per calendar year, subject to the terms of the respective policies and date of hire.
• J&J Flex position with minimum three days of on-site work; no full-time remote option.

Company

• Healthcare innovation, pharmaceuticals, and medical technology
• New Brunswick, New Jersey, USA
• http://www.jnj.com/
• Founded in 1886
• 10001+ employees

Qualifications

• Minimum of a bachelor's degree required
• Demonstrated intellectual capacity to identify, read, understand, and address global medical device regulations are required
• Must have excellent written, verbal communication, and presentation skills
• 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

Required skills

• 510(k) Submissions, European Technical Files and Design Dossiers, Medical Device Regulations, Medical Device Regulatory Filings, PMA Submissions

Preferred skills

• advanced degree strongly preferred

Experience

• Entry level