Job Title

1 week ago Be among the first 25 applicantsGet AI-powered advice on this job and more exclusive features.This range is provided by i-Pharm Consulting. Your actual pay will be based on your skills and experience talk with your recruiter to learn more.Base pay rangeA$120,000.00/yr - A$140,000.00/yrDirect message the job poster from i-Pharm ConsultingRecruiting Regulatory Affairs & Quality Assurance Professionals across Australia & New ZealandAre you a skilled Regulatory Affairs professional looking to join a global leader in the medical device industry? Whether you''re an established Regulatory Affairs Lead or a Senior professional looking to take the next step into a lead role, this dynamic opportunity offers the chance to play a pivotal part in ensuring compliance and regulatory excellence for cutting-edge healthcare products. As the Regulatory Affairs Lead, you will take ownership of technical documentation, collaborate with cross-functional teams, and contribute to the success of innovative healthcare solutions.Responsibilities:Own and maintain content of technical files for medical device products.Collaborate with the global Regulatory Affairs team to incorporate region-specific requirements into product documentation.Ensure regulatory compliance throughout the product lifecycle.Lead the regulatory aspects of product development, working closely with Product Development and Product Management teams.Manage and update technical files in line with product design and changes.Provide guidance on regulatory processes, offering internal training and promoting awareness across the organisation.Lead or participate in process improvement projects to streamline regulatory functions.Support post-market surveillance activities and assist with audits and regulatory agency reviews.Mentor junior members of the Regulatory Affairs team.Skills:3-5 years of experience in the medical device industry.Strong background in medical device development and regulatory compliance.Experience with regulatory submissions, change management, and risk management processes.Tertiary qualifications in Regulatory Affairs, Engineering, Science, or a related discipline.Apply directly now, or send your updated CV to Ben Byrne at bbyrne@i-pharmconsulting.com OR (04) 21776703Seniority levelSeniority levelMid-Senior levelEmployment typeEmployment typeFull-timeJob functionJob functionScienceIndustriesMedical Equipment ManufacturingReferrals increase your chances of interviewing at i-Pharm Consulting by 2xGet notified about new Regulatory Affairs Specialist jobs in Sydney, New South Wales, Australia.APAC Regulatory Specialist - Australia (12 month contract)Millers Point, New South Wales, Australia 1 week agoSydney, New South Wales, Australia 5 days agoMacquarie Park, New South Wales, Australia 4 hours agoSydney, New South Wales, Australia A$100,000.00-A$140,000.00 4 days agoCompliance, Regulatory Compliance, Analyst, SydneyMacquarie Park, New South Wales, Australia 2 weeks agoSydney, New South Wales, Australia 2 hours agoSt Leonards, New South Wales, Australia 1 week agoRegulatory Affairs Pharmacovigilance Lead AustraliaSydney, New South Wales, Australia 1 month agoTobacco Regulatory Control Officer - 12 x rolesSt Leonards, New South Wales, Australia 1 week agoSydney, New South Wales, Australia 5 days agoSydney, New South Wales, Australia 2 hours agoRegulatory Compliance Officer (Australia & New Zeland)Sydney, New South Wales, Australia 1 month agoSydney, New South Wales, Australia 4 days agoHead of Regulatory Advisory, Australia - DirectorSydney, New South Wales, Australia 4 days agoSydney, New South Wales, Australia 6 days agoManager, Scientific and Regulatory AffairsSydney, New South Wales, Australia 8 hours agoSydney, New South Wales, Australia 2 weeks agoParramatta, New South Wales, Australia 6 days agoAirport Standards, Service and Quality SpecialistSenior Tobacco Regulatory Control Officer - 2 x rolesSt Leonards, New South Wales, Australia 1 week agoWarriewood, New South Wales, Australia 1 week agoQuality & Performance Specialist Financial Crime OperationsEveleigh, New South Wales, Australia 5 days agoAssistant Company Secretary & Regulatory AffairsSydney, New South Wales, Australia 14 hours agoSydney, New South Wales, Australia 4 days agoProduct Specialist - Regulatory ComplianceSydney, New South Wales, Australia 6 days agoQuality, Governance & Assurance SpecialistSydney, New South Wales, Australia 2 days agoParramatta, New South Wales, Australia 4 days agoNorth Sydney, New South Wales, Australia 6 days agoSydney, New South Wales, Australia 4 days agoNorth Sydney, New South Wales, Australia 5 days agoSydney, New South Wales, Australia 2 weeks agoDeputy General Counsel - Regulatory Legal ServicesSydney, New South Wales, Australia 3 days agoProduct Specialist - Regulatory ComplianceMillers Point, New South Wales, Australia 2 days agoWere unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr