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. 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.
Johnson & Johnson announced plans to separate its 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. 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.
You 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.
•Work with team members to determine regulatory impact of manufacturing and/or product changes, prepare and submit applications, and 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.
•Provide 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
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
Pay
The anticipated base pay range for this position is $76,000.00 - $121,900.00.
Time off benefits (subject to respective policies and date of hire)
•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
•Volunteer Leave – 32 hours per calendar year
•Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits: https://www.careers.jnj.com/employee-benefits
