Regulatory Affairs Specialist I – Spine

DePuy Synthes Companies of Johnson & Johnson is hiring a Regulatory Affairs Specialist I – Spine. The role supports regulatory strategies, submissions, product and labeling compliance, and regulatory authorization for spine products in US and international markets.

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
• 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
• Highly Regulated Industry Experience
• Medical Device Industry Experience
• Regulatory Filing Preparation
• Regulatory Filing Submission
• 510(k) Filings
• PMA Filings
• European Technical Files
• Design Dossiers
• US Regulatory Processes
• European Regulatory Processes

Benefits

• J&J Flex position with minimum three days of on-site work; there is no full-time remote option.
• Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible to participate in the Company’s long-term incentive program.
• Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: 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.

Company

• Medical device solutions for surgery, orthopaedics, cardiovascular, and vision
• New Brunswick, New Jersey, USA
• https://www.jnjmedtech.com/en-US
• Founded in 1886
• 10001+ employees

Qualifications

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

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

Preferred skills

• advanced degree strongly preferred

Experience

• Entry level