Regulatory Affairs Analyst

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

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.

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About Orthopaedics

Fueled by innovation at the intersection of biology and technology were 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 thats 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 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 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.

Qualifications

Education:

• Minimum of a bachelors 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.

Johnson & Johnson is an Affirmative 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

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