The Regulatory Affairs Specialist II

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.

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Boston Massachusetts United States of America Palm Beach Gardens Florida United States of America Raynham Massachusetts United States of America Warsaw Indiana United States of America West Chester Pennsylvania United States of America

Job Description:

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 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 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 The Regulatory Affairs Specialist II in Warsaw IN West Chester PA Raynham MA Palm Beach Gardens FL

Purpose:

The Regulatory Affairs Specialist II will execute regulatory activities to support currently marketed devices and new product development in the DePuy Synthes Joint Reconstruction and VELYS Digital Surgery line of products. This role involves a multi-faceted set of skills including sound regulatory judgment cross-functional collaboration and planning/oversight/execution of projects & activities that directly impact the operational results of the business.

Y ou will be responsible for:

In accordance with all applicable federal state and local laws/regulations and Corporate

Johnson & Johnson procedures and guidelines this position will:

Prepare and/or assist in preparation of regulatory documentation for DePuy devices including IDE 510(k) PMA Technical File Design Dossier and Technical Documentation for submission to regional Health authorities. This includes the resolution of regulatory issues and questions from regulatory agencies during the pre-market product development phase interacting with regulatory agencies regarding submissions.

Assist in the preparation of approval documents to support rest of world registrations such as EU CE marking activities as required.

Review engineering changes to currently marketed products and prepare internal regulatory

assessments for documenting decisions to submit or not to submit in accordance with relevant regulations and guidance.

Works with team members to determine regulatory impact of manufacturing and/or changes on products prepare and submit applications and the assess the impact product changes have on the status of regulatory licenses.

Review product labeling and product support information for currently marketed products to

ensure that product information and claims are consistent with premarket clearances and

approvals and in compliance with relevant regulations and guidance.

Provides product information and regulatory guidance and support to project teams including processing design control changes providing guidance and review of promotional materials and communicating regulatory pathways.

Maintain current knowledge to ensure compliance to the applicable regulatory and corporate

standards/requirements (FDA Quality System Regulations European Quality Standards and

Medical Device Regulation ISO 13485 previous MDD MDR etc.).

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:

BA/BS degree with minimum 2 years Regulatory Affairs experience in medical devices.

Experience with US FDA Regulations and European Medical Device Regulations (and previous Medical Device Directives) required

Required Knowledge Skills Abilities Certifications/Licenses and Affiliations:

Excellent written and oral communications skills
Ability to handle multiple tasks and be detail oriented

Knowledge of medical devices with preference for orthopaedics capital equipment robotics and software

Familiarity with electronic submission preparation

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 and 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 email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

Analytical Reasoning Business Behavior Business Writing Collaboration Communication Confidentiality Data Reporting Data Savvy Detail-Oriented Execution Focus Legal Support Medicines and Device Development and Regulation Regulatory Affairs Management Regulatory Compliance Regulatory Development Regulatory Environment Risk Assessments

The anticipated base pay range for this position is :

$76000.00 - $121900.00

Additional Description for Pay Transparency:

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: - Experience:

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