Regulatory Affairs Specialist II (Power Tools) Orthopaedics

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

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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 & Johnson announced plans to separate our Orthopaedics business toestablish 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 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 Regulatory Affairs Specialist II to support our Power Tools business. This role must be based within a commutable distance of Palm Beach Gardens FL Raynham MA. There is NO remote option available.

Purpose: The Regulatory Affairs Specialist II provides regulatory guidance to project teams in strategic planning and related submissions to support Orthopeadics Velys power products. Under minimal supervision the individual develops and executes regulatory strategy for significant change supplements and 510(k) registrations to support continued commercialization of products in key countries. The Regulatory Affairs Specialist II helps to define data and information needed for regulatory actions in conjunction with cross-functional teams. He/she guides conformance with applicable regulations through the development of best practices for Regulatory Affairs processes procedures and systems.

You will be responsible for:

• Ensures compliance with regulatory agency regulations and interpretations.
• Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
• Prepares responses to regulatory agencies questions and other correspondence.
• Provides key deliverables in a timely manner and in accordance with project team expectations and regulatory project plan timelines (e.g. regulatory strategy regulatory change assessment etc.)
• Researches and collects data; and responds to requests from regulatory agencies and/or distributors to prepare and submit documentation for marketing approvals as well as to provide routine regulatory information to associates and affiliates.
• Advises on regulatory labeling requirements specifications for modified products and reviews product labeling to ensure compliance.
• Conduct regulatory promotional labeling and marketing compliance reviews ensuring activities and communications are consistent with product labeling are adequately supported and are following applicable laws regulations and policies related to advertising & promotion of regulated products.
• Represents Regulatory Affairs on cross-functional project teams and provides regulatory guidance.
• Provides solutions to a variety of problems of moderate scope and complexity.
• Provide Regulatory Affairs support during internal and external audits.
• Assists in the development of best practices for Regulatory Affairs processes.
• Responsible for communicating business related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health Safety and Environmental practices as applicable.
• For those who supervise or manage a staff responsible for ensuring that subordinates follow all Company guidelines related to Health Safety and Environmental practices and that all resources needed to do so are available and in good condition if applicable.
• Responsible for ensuring personal and Company compliance with all Federal State local and Company regulations policies and procedures.
• Performs other duties assigned as needed.

Qualifications / Requirements:

• 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.
• At least 2 years of professional regulatory experience in a highly regulated industry required preferably in medical device (1 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) as well as European technical documentation reports files is strongly preferred.
• Knowledge of U.S. and European regulatory processes is preferred.

• Ability to work both independently and in a team environment to problem solve and recognize and find solutions for gaps in processes is desirable.
• Leverages scientific and technical understanding of regulated products within scope of responsibility to provide regulatory input to product lifecycle management and evaluate regulatory impact on products.
• Demonstrates the ability to contribute to the development of effective and results-oriented regulatory strategic plans that are in line with business objectives.
• Consults with others to understand the benefits risks and Credo-based impact associated with decision alternatives before making decisions.
• Deliver by acting with speed flexibility accountability and appropriately managing priorities to deliver results for on-time clearances.
• Shape by challenging the status quo and adapting to change taking advantage of opportunities to have a positive impact.
• Lead by leveraging diverse perspectives backgrounds and talent to generate effective ideas or solutions.
• Connect by encouraging and supporting internal collaboration across levels creating effective solutions. Builds and leverages internal and external networks with colleagues cross-functional partners and industry contacts to identify opportunities and open communication channels.

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 or contact AskGS to be directed to your accommodation resource.

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