{"schemaVersion":"jobsearcher.job.v1","id":"6b83bef940ea0f4a82620bea","url":"https://jobsearcher.com/jobs/6b83bef940ea0f4a82620bea","canonicalUrl":"https://jobsearcher.com/jobs/6b83bef940ea0f4a82620bea","title":"Quality Systems Engineer","description":"Job SummaryWe are seeking a detail-oriented and knowledgeable Regulatory Affairs Specialist to support regulatory submissions, product compliance, and global registration activities for pharmaceutical, biotech, medical device, and life-science clients. This role is essential for ensuring that all products, processes, and documentation meet the requirements of FDA, EMA, MHRA, and other international regulatory authorities. The ideal candidate is experienced in documentation, regulatory strategy, and cross-functional collaboration within highly regulated environments.\r\nKey ResponsibilitiesPrepare, review, and submit regulatory documents including IND, NDA, ANDA, DMF, 510(k), CE Marking files, and other global submissions.\r\nEnsure compliance with FDA, EMA, WHO, MHRA, and international regulatory frameworks.\r\nMaintain up-to-date knowledge of global regulations affecting pharmaceutical, biotech, and medical device products.\r\nSupport clients during regulatory audits and inspections by ensuring required documentation and records are complete.\r\nCoordinate with R&D, Quality, Manufacturing, and Clinical teams to gather information for submissions.\r\nMonitor regulatory changes and communicate their impact to internal teams and clients.\r\nReview product labeling, marketing materials, and technical documentation for regulatory accuracy.\r\nAssist in lifecycle management of products, including variations, renewals, and post-approval changes.\r\nSupport the development of regulatory strategies for new products, markets, and technology lines.\r\nQualificationsBachelor’s or Master’s degree in Life Sciences, Regulatory Affairs, Pharmacy, Biotechnology, or a related field.\r\n2–6 years of experience in regulatory affairs in pharma, biotech, or medical devices.\r\nStrong understanding of FDA, EMA, ICH, and global regulatory pathways.\r\nExcellent knowledge of submission formats including eCTD and technical documentation requirements.\r\nStrong communication, documentation, and analytical skills.\r\nAbility to manage multiple projects with tight timelines.\r\nPreferred SkillsExperience with digital regulatory systems or eCTD publishing tools.\r\nKnowledge of GMP, GDP, and ISO 13485 regulatory interactions.\r\nFamiliarity with clinical research submissions (CTA, IND amendments, safety reports).\r\nUnderstanding of quality systems and risk management frameworks.\r\nWhy Join Us?Opportunity to work on global regulatory projects across multiple industries.\r\nExposure to innovative technologies and diverse regulatory frameworks.\r\nProfessional growth in a supportive, compliance-driven environment.\r\nWork on high-impact projects that contribute to patient safety and public health.#J-18808-Ljbffr","company":"Efficient Auditing","rawCompany":"efficient auditing","city":"Millbrae","state":"CA","isRemote":false,"isActive":false,"createdAt":"2026-10-10T01:16:38.191Z","occupations":[{"code":"13-1041.07","title":"Regulatory Affairs Specialists","slug":"regulatory-affairs-specialists"},{"code":"11-9199.01","title":"Regulatory Affairs Managers","slug":"regulatory-affairs-managers"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"}],"industries":[{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"},{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Quality Systems Engineer","description":"Job SummaryWe are seeking a detail-oriented and knowledgeable Regulatory Affairs Specialist to support regulatory submissions, product compliance, and global registration activities for pharmaceutical, biotech, medical device, and life-science clients. This role is essential for ensuring that all products, processes, and documentation meet the requirements of FDA, EMA, MHRA, and other international regulatory authorities. The ideal candidate is experienced in documentation, regulatory strategy, and cross-functional collaboration within highly regulated environments.\r\nKey ResponsibilitiesPrepare, review, and submit regulatory documents including IND, NDA, ANDA, DMF, 510(k), CE Marking files, and other global submissions.\r\nEnsure compliance with FDA, EMA, WHO, MHRA, and international regulatory frameworks.\r\nMaintain up-to-date knowledge of global regulations affecting pharmaceutical, biotech, and medical device products.\r\nSupport clients during regulatory audits and inspections by ensuring required documentation and records are complete.\r\nCoordinate with R&D, Quality, Manufacturing, and Clinical teams to gather information for submissions.\r\nMonitor regulatory changes and communicate their impact to internal teams and clients.\r\nReview product labeling, marketing materials, and technical documentation for regulatory accuracy.\r\nAssist in lifecycle management of products, including variations, renewals, and post-approval changes.\r\nSupport the development of regulatory strategies for new products, markets, and technology lines.\r\nQualificationsBachelor’s or Master’s degree in Life Sciences, Regulatory Affairs, Pharmacy, Biotechnology, or a related field.\r\n2–6 years of experience in regulatory affairs in pharma, biotech, or medical devices.\r\nStrong understanding of FDA, EMA, ICH, and global regulatory pathways.\r\nExcellent knowledge of submission formats including eCTD and technical documentation requirements.\r\nStrong communication, documentation, and analytical skills.\r\nAbility to manage multiple projects with tight timelines.\r\nPreferred SkillsExperience with digital regulatory systems or eCTD publishing tools.\r\nKnowledge of GMP, GDP, and ISO 13485 regulatory interactions.\r\nFamiliarity with clinical research submissions (CTA, IND amendments, safety reports).\r\nUnderstanding of quality systems and risk management frameworks.\r\nWhy Join Us?Opportunity to work on global regulatory projects across multiple industries.\r\nExposure to innovative technologies and diverse regulatory frameworks.\r\nProfessional growth in a supportive, compliance-driven environment.\r\nWork on high-impact projects that contribute to patient safety and public health.#J-18808-Ljbffr","datePosted":"2026-10-10T01:16:38.191Z","dateModified":"2026-10-10T01:16:38.191Z","hiringOrganization":{"@type":"Organization","name":"Efficient Auditing","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Millbrae","addressRegion":"CA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"6b83bef940ea0f4a82620bea"},"url":"https://jobsearcher.com/jobs/6b83bef940ea0f4a82620bea"}}