Regulatory Affairs Specialist I – Spine

6029-MEDICAL DEVICE BUSINESS SERVICES, INC. Legal Entity; Raynham (MA); On-site; USD 64,000 - 102,000; Full time

Benefits offered by this job

Vacation –120 hours per year

Sick time – 40 hours per year; varies

Holiday pay (13 days)

Parental Leave – 480 hours

Bereavement Leave – 240 hours

Job summary

DePuy Synthes, a Johnson & Johnson company, is recruiting a Regulatory Affairs Analyst – Spine on-site in Raynham, MA. You will guide product development teams on regulatory strategies and lead critical submissions to health authorities globally.

The role requires a bachelor’s degree (advanced degree preferred), experience with US FDA filings (510(k), PMA) and European technical files, and strong communication skills. Travel up to 10% may be required.

Qualifications

• Bachelor's degree required; advanced degree preferred.
• Experience with US FDA filings (510(k)) and European technical files is strongly preferred.
• Knowledge of US and European regulatory processes; excellent written, verbal communication, and presentation skills.

Responsibilities

• Provides regulatory guidance to product development teams in defining regulatory strategies and submissions.
• Executes submission of licenses and registrations including 510(k), PMA and international dossiers.
• Guides conformance with regulations in labeling and promotional materials.
• Defines data needed for regulatory marketing authorizations.
• Develops labeling specifications and approves labeling, packaging, and promotional materials.
• Provides regulatory support during internal and external audits.
• Represents Regulatory Affairs on cross-functional teams for US and international issues.
• Responds to requests from foreign governments and distributors for documentation.

Skills

Regulatory affairs

US FDA submissions (510(k))

EU regulatory processes

Verbal and written communication

Education

Bachelor's degree

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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: About Orthopaedics Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Orthopaedics? Ready to join a team that’s reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

DePuy Synthes Companies of Johnson & Johnson is recruiting for a Regulatory Affairs Analyst – Spine, located on-site in Raynham, MA. This is a J&J Flex position with minimum three days of on-site work. There is no full-time remote option.

Key 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 documentation 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

Qualifications

• Education: Minimum of a bachelor’s degree required, advanced degree strongly preferred. Desired fields of study include science, engineering (e.g., biomedical, electrical, software, mechanical), business, legal, or similar.
• Experience and Skills: Experience in a highly regulated industry preferred, preferably with medical devices. Relevant internship experience may be considered. Demonstrated intellectual capacity to identify, read, understand, and address global medical device regulations are required. 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. Must have excellent written, verbal communication, and presentation skills.
• Other: This position will be located in Raynham, MA, and may require up to 10% domestic and international travel.

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone Orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Affiliation and Equal Opportunity Statement

Johnson & Johnson is an Affitraitive Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against based on disability.

For more information on how we support the whole health of our employees throughout their wellness, career, and life journey, please visit www.careers.jnj.com.

The anticipated base pay range for this position is : $64,000.00 - $102,350.00

Additional Description for Pay Transparency: 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.

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
• 10 days Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.