Senior Regulatory Affairs Specialist (Spine) - MedTech Orthopaedics

Johnson & Johnson • Full-time • US014 MA Raynham - 325 Paramount Dr, United States of America • 5d ago

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:

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

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.

Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

We are searching for the best talent for a Senior Regulatory Affairs Specialist to support our Spine business. This role must be based within a commutable distance of Raynham, MA. There is NO remote option available.

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 regulatory authorization for various changes to product, procedures, etc.
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 / Requirements:

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.
Minimum 5+ years of regulatory affairs experience in a highly regulated industry, preferably in medical device (3+ years with advanced degree).
Demonstrated intellectual capacity to identify, read, understand, and address global medical device regulations are required.
Experience in the preparation and submission of U.S. regulatory filings (e.g., 510(k), PMA) and/or European technical documentation reports files is strongly preferred.
Knowledge of U.S. and European regulatory processes is preferred.
Must have excellent written, verbal communication, collaborative and strong attention to detail skills.
High organizational skills with the ability to lead multiple projects/tasks simultaneously and effectively prioritize projects and tasks.
Strong learning skills for complex technology and presentation skills to allow presentation of complex regulatory strategies in a clear, concise, and comprehensive fashion.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is :

$92,000.00 - $148,350.00

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)).

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 period10 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

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