Regulatory Affairs Manager

Regulatory Affairs ManagerAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity.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; ZuchwilFueled 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.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.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:Required: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 internationalJohnson & 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 (View email address on click.appcast.io) or contact AskGS to be directed to your accommodation resourceThe anticipated base pay range for this position is: $117,000.00 - $201,250.00Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). 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 period 10 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: -