Job Description SummaryYou will be responsible for providing regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance. You will work closely with healthcare regulatory bodies globally.Job DescriptionResponsibilitiesFile / Maintain regulatory deliverablesAnalyze and communicate changes and proposed changes to country regulations through Regulatory Intelligence and implement strategiesSupport local regulatory authority / notified body inspections as requiredEducate, train, and advise company professionals to ensure compliance with regulatory requirementsCoach and mentor other RA professionalsPremarket Create regulatory compliance / project plan with Product RA to ensure all requirements are met for country Regulatory market clearance submissions and liaise with relevant personnel to ensure appropriate, timely input is provided for submissionsCommunicate with Product RA resources to establish regulatory requirements, including clinical trial data.Provide RA support as needed to clinical studies to ensure regulatory requirements are met.Partner with Product RA professionals to review advertising and promotion materials for country or regional compliance and approve these as required.Act as liaison with external regulatory reviewers to gain rapid approval of submissions.Work with appropriate Product RA representative for countries with license expiration requirements, to establish plans and deliverables for timely submission for renewal of license.Support regulatory compliance and optimization of quality system procedures relating to new product registration submissions through the development, maintenance and improvement of documented processes.Postmarket Review new reportable adverse events for country reportability.Prepare Recall submissions, localize if applicable.Prepare Regulatory Authority responses to inquiries; work with the P&L to ensure accurate response. Following PSRB decision, review field action information to determine if reportable in local country.Support regulatory compliance and optimization of quality system procedures relating to post market reporting through the development, maintenance and improvement of documented processes.Act as liaison with external regulatory bodies, as required, to ensure appropriate and timely responses are provided to inquiries regarding product reports.Provide evidence of official closure of postmarket actions ( AERs and Recalls) to the P&L.Monitor external information for incidents or issues that may involve product; communicate information internally in a timely manner. Required QualificationsAdvanced degree in scientific, technology or legal disciplines.Minimum of 5 years experience in the medical device or equipment or with medical product regulatory agencies; progressive regulatory affairs experience in medical device or equipment industry or with medical product regulatory agencies, including knowledge and experience applying device laws and regulations for product registration, adverse event reporting, and recallsProven application of analytical skills in a regulatory environmentExcellent verbal and written communication and presentation skills.Demonstrated knowledge and experience conducting scientific, regulatory, legal, or business research.Strong problem solving and negotiation skillsAbility to work well independently and in a team setting. Prior experience using spreadsheet and presentation software.Regulatory Affairs Certification (RAPS).Demonstrated experience interfacing with regulatory agencies ( PPB, TMDA, EFDA, RPB, RFDA etc.) and standards bodies such as IEC, ISO, UL.Knowledge of Quality Management Systems (QMS)Demonstrated experience prioritizing conflicting demands from multiple business entities in an extremely fast paced environment.Demonstrated understanding of healthcare environment and knowledge of current competitive, commercial or political situations and their impact on GE HealthCare regulatory strategies.Ability to prioritize, plan and evaluate deliverables to established strategic goals.Must be willing to travel up to 10% of time.Experience with working across cultures/countries/sitesInclusion and Diversity
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