Senior Regulatory & Quality Lead - FDA/ISO 13485 Expert
Medit-USA-Inc
Medit-USA-Inc is searching for a Senior RA/QA expert to manage regulatory and quality operations across the U.S., Canada, and LATAM. The successful candidate will lead FDA Class II 510(k) submissions and ensure compliance with ISO 13485. This role requires strong leadership and project management skills with 7–10+ years of relevant experience. Fluency in English is essential; Spanish or Portuguese is a plus. Experience in cross-border environments will be advantageous. #J-18808-Ljbffr Medit-USA-Inc
$126k - $138k
...QMS Internal Auditor who will play a crucial role in ensuring quality standards and regulatory compliance for our life-saving artificial heart technology. This position requires strong expertise in ISO 13485 and direct internal auditing experience. The expected salary...QualitySeniorRegulatory- Anduril Industries is seeking a Senior Materials Manager in Costa Mesa, CA to design and implement... ...involves developing material management strategies, leading high-performing teams, and ensuring compliance with safety and quality protocols. Competitive salary and top-tier...QualitySenior
- Anduril Industries in Costa Mesa, CA, is seeking a Manager, Subcontracts to lead a growing team and drive major subcontractor developments across programs. You will collaborate with engineering, quality, manufacturing, legal, and suppliers to navigate complex FAR/DFARs-...QualitySeniorContract workFor subcontractor
- ...countries. Our industry-leading intraoral scanners... ...America, we are seeking a senior-level RA/QA expert to own and lead our... ...full ownership of regulatory and quality operations across the... ...and LATAM — including FDA Class II 510(k) submissions, ISO 13485 quality systems, and...QualitySeniorRegulatoryLocal areaWorldwide
$155k - $169.99k
...intersection of quality engineering... ...development. As Senior Manager, Quality... ...will not only lead the QE team in... ...controls, and regulatory compliance — you... ..., aligned with ISO 13485, 21 CFR Part 8... ...surveillance audits and FDA inspections... ...Expertise Expert knowledge of IEC...QualitySeniorRegulatoryRelocation packageDay shift$126k - $138k
...report on internal quality system audits in accordance with ISO 13485:2016, 21 CFR Part 820, and FDA IDE requirements. This... ...Director of QA & Regulatory Affairs. Key Responsibilities... ...criticality. Lead and conduct internal... ...and subject matter experts to schedule and...QualitySeniorRegulatoryRelocation packageFlexible hoursDay shift$150k - $165k
...165,000.00/yr The Senior Quality Systems Manager will... ...in alignment with FDA, ISO, and global... ...regulations. This role also leads and develops the... ...compliance with regulatory and ISO... ...standards, including ISO 13485, FDA QSR, EU MDR,... ...knowledge in a new way. Experts add insights...QualitySeniorRegulatoryFull timeLocal area- ...investigations and recommend corrective actions. Supply quality control data necessary for regulatory submissions Receive and inspect raw materials.... ...by following standards and procedures; complying with (ISO 9001 & AS9100), government regulation standards, and agency...QualityRegulatoryPermanent employmentFor contractorsLocal area
$86k - $114k
Anduril Industries is seeking an Accounts Payable Supervisor in Costa Mesa, CA to oversee AP operations, improve processes, and manage vendor relationships. Candidates should have 7+ years of relevant experience, particularly with Oracle Fusion. The compensation ranges ...Senior- Mach Industries in Huntington Beach, CA, seeks a Senior Avionics Specialist to perform deep-dive analysis and advanced troubleshooting... ...with design teams, and thorough documentation for regulatory compliance; candidates should have 5+ years of hands-on experience...SeniorRegulatory
- ...investigations and recommend corrective actions. Supply quality control data necessary for regulatory submissions. Receive and inspect raw materials.... ...by following standards and procedures; complying with ISO 9001 & AS9100, government regulation standards, and agency...QualityRegulatoryPermanent employment
- Anduril Industries is seeking a Senior Program Manager, Physical Security Operations to shape enterprise security strategy across its... ...leadership to anticipate threats, establish governance, and balance regulatory compliance with rapid growth. #J-18808-Ljbffr Mosaic.techSeniorRegulatory
- Hydrogen UK Ltd is looking for a Senior-level quality professional based in California to provide technical leadership in batch documentation... .... The role involves oversight of manufacturing records, regulatory compliance, and mentorship of quality specialists. The ideal...QualitySeniorRegulatory
$92k - $148.35k
...Cardiovascular team develops leading solutions for heart... ...best talent for a Senior R&D Engineer to... ...verification and validation, FDA submission, and... ...analysis Assist regulatory compliance efforts and... ...Ability to work within an ISO structured quality system Knowledge...QualitySeniorRegulatoryWork at officeLocal areaImmediate start$81.65k - $112.7k
...standards of care. The Senior Manufacturing... ...products are high quality, low cost and meet... ...materials, R&D, quality, regulatory and marketing... ...manufacturers and suppliers. Lead External... ...of experience in an FDA-regulated industry... ...requirements (e.g., QSRs, ISO & MDD) Proficient...QualitySeniorRegulatoryTemporary workLocal area$146k - $194k
Anduril in Costa Mesa, CA, is looking for a Senior Technical Writer to lead documentation efforts for military technologies. The successful candidate... ...to create user-friendly documentation and maintain the quality standards expected by government clients. This role...QualitySenior$191k - $253k
Neura Market is seeking a Director of Quality for Product Quality Engineering. This role involves supporting the VP of Quality, optimizing team performance, and ensuring compliance with regulatory standards. The ideal candidate must have a Bachelor's degree in engineering...QualitySeniorRegulatory- ...Regulatory Affairs Specialist Responsibilities: Represent Regulatory... ...in a regulated industry (FDA and Software as a Medical... .... Strong knowledge of FDA Quality System Regulations, including... ...MDCG 2019-11, MDCG 2020-1), ISO 13485, and MDSAP, ISO 14971, ISO 6...QualitySeniorRegulatory
- SprintRay Inc. in Huntington Beach, CA is seeking a highly motivated Regulatory Affairs and Quality Assurance Specialist to support their medical device portfolio. This fulltime onsite role involves ensuring compliance with global regulatory standards, reviewing product...QualitySeniorRegulatoryFull time
$146k - $194k
Anduril Industries in Costa Mesa, California, is looking for a Lead Manufacturing Engineer to join our innovative Propulsion Manufacturing... ...team and oversee the manufacturing value-chain, ensuring high-quality production of cutting-edge defense hardware. We're seeking...QualitySenior$146k - $194k
...months, not years. ABOUT THE TEAM As a Lead Product Quality Engineer you will work inside and... ...suppliers. Working knowledge of AS9100/ ISO 9001-based Quality Management System requirements... ...contracts and mil standard or other regulatory requirements. Experience with...QualitySeniorRegulatoryFull timeWork experience placement- Anduril Industries is seeking a Quality Supervisor to lead a team of inspectors, develop quality processes, and ensure safe, high‑quality products... ...initiatives while preparing for internal audits and regulatory compliance. A strong background in AS9100 and Lean methods...QualityRegulatory
$86k - $114k
Slope in Costa Mesa, California, is seeking a Quality Supervisor to lead and develop a team of quality control inspectors. The role focuses on... ...qualifications include over 5 years of experience in Quality and/or Regulatory roles, a strong understanding of AS9100 standards, and...QualityRegulatory$146k - $194k
Anduril Industries is seeking a Senior Supplier Industrialization Engineer in Costa Mesa, CA. This role is vital for enabling and... ...engines. Responsibilities include managing supplier relationships, leading quality assurance efforts, and enhancing production strategies. The...QualitySenior$191k - $253k
...California. This role involves managing avionics projects and contributing to flight test operations with a focus on high standards of quality and technical execution. The ideal candidate will have significant hands-on experience in avionics, advanced troubleshooting, and...QualitySenior- ...provide fiduciary expertise and deliver high-quality fiduciary solutions to clients. You will manage personal trusts, ensure regulatory compliance, and deepen client relationships... ...documents, and serve as a subject matter expert in fiduciary #J-18808-Ljbffr Fifth Third BankQualitySeniorRegulatory
- ...Job Summary The Sr Quality Engineer will support product development and cleanroom build... ...ensuring compliance with quality systems, regulatory standards, and supporting design... ...theories, and concepts Understanding of ISO 13485 Experience developing, updating, and maintaining...QualitySeniorRegulatory
- Pacific Life is seeking a Senior Systems Analyst to join its Legal & Compliance Technology... ..., and Technology by translating regulatory requirements into technology solutions.... ...document complex business requirements, manage quality assurance, and support test automation...QualitySeniorRegulatory
$100k - $150k
...Now Hiring: Senior Immigration Attorney – Newport Beach, CA (On-Site) David Hirson & Partners... ...while maintaining exceptional quality and client service. Salary Range: $100,0... ...case oversight to ensure timely filings, regulatory compliance, and adherence to firm policies...QualitySeniorRegulatoryH1bEb 3 Visa SponsorshipImmediate start$172.6k - $265.7k
...Orthopedic Solutions is world leading Medical Device Contract... ...markets. We are also FDA registered and ISO 13485 certified. A career with... ...and delivering exceptional quality, service, and innovation.... ...Experience Manufacturing Regulatory Environment - Working Experience...QualityRegulatoryHourly payFull timeContract workWork experience placementWork visaShift work
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