Regulatory Affairs Manager

6029-MEDICAL DEVICE BUSINESS SERVICES Legal Entity • West Chester, FL

20h • Hybrid

About The Position

We are searching for the best talent to join our DePuy Synthes Orthopaedics team as a Regulatory Affairs Manager. This position may be based in Raynham, MA; West Chester, PA; Palm Beach Gardens, FL; Synthes, Oberdorf; Zuchwil 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 Orthopedics? Ready to join a team that’s reimagining how we heal? Our Orthopedics 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.

Requirements

• Bachelor’s degree or equivalent
• 6 years of related experience
• Experience in the Medical Device industry or medical field

Nice To Haves

• Experience with power devices is highly preferred
• Demonstrated knowledge of US and EU Medical Device Regulations preferred
• RAC (Regulatory Affairs Certification) by Regulatory Affairs Professional Society or advanced degree in Regulatory Affairs, desirable

Responsibilities

• Provides independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launches
• Manages the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers
• 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
• Plans schedules for regulatory deliverables on a project and monitors project through completion
• Leads in the development of best practices for Regulatory Affairs processes
• Represents Regulatory Affairs on cross-functional project teams
• Partners with other functions to define and obtain data to assist with regulatory submissions
• May work with International Affiliates directly
• Provide Regulatory Affairs support during internal and external audits
• 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

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 period
• 10 days Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Manager