Regulatory Affairs Manager

Regulatory Affairs ManagerWe are searching for the best talent to join our DePuy Synthes Orthopaedics team as a Regulatory Affairs Manager. This position may be based in Synthes, Oberdorf; Zuchwil or US: Raynham, MA; West Chester, PA; Palm Beach Gardens, FLFueled 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.Summary: The RA manager leads a team to provide independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launches. Under minimal supervision, the individual leads the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers. Guide conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials. The RA manager serves as the company's regulatory expert and is responsible for communications with FDA and international regulatory agencies.You will:Provides independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launchesManages the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiersGuides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materialsDefines data and information needed for regulatory approvalsDevelops labeling specifications and approves proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulationsPlans schedules for regulatory deliverables on a project and monitors project through completionLeads in the development of best practices for Regulatory Affairs processesRepresents Regulatory Affairs on cross-functional project teamsPartners with other functions to define and obtain data to assist with regulatory submissionsMay work with International Affiliates directlyProvide Regulatory Affairs support during internal and external auditsResponsible for communicating business related issues or opportunities to next management levelResponsible 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 applicableResponsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and proceduresPerforms other duties assigned as neededQualifications:Bachelor's degree or equivalent6 years of related experienceExperience in the Medical Device industry or medical fieldPreferred:Experience with power devices is highly preferredDemonstrated knowledge of US and EU Medical Device Regulations preferredRAC (Regulatory Affairs Certification) by Regulatory Affairs Professional Society or advanced degree in Regulatory Affairs, desirableOther:Ability to travel up to 10% may be required both domestic and international