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- ...professionals to drive timely product approvals and ensure ongoing regulatory compliance in key markets such as USA (FDA), EU (MDR), China (NMPA), and more You will work cross-functionally with Clinical, Global Regulatory Affairs counterparts, and others to support innovation...SuggestedWork at office
$225k - $285k
...and their outcomes remain compliant. The role will provide expert GCP guidance across global regulatory requirements (FDA, EMA, MHRA, NMPA, PMDA, etc.) and ensure compliance with ICH GCP, FDA, EMA, and other relevant global regulations. The role will collaborate cross-...SuggestedContract workRemote work- ...continuous improvement and risk mitigation strategies.Monitor, interpret, and communicate evolving global CMC regulations (FDA, EMA, PMDA, NMPA, etc.). Ensure timely dissemination of regulatory intelligence to internal stakeholders and integration into strategic planning....SuggestedFull timeFlexible hours
$178.5k - $257.83k
...regulatory expectationsLead and support external health authority engagement and regulatory interactions (FDA, EMA, Notified Bodies, NMPA) across combination products, medical devices, and SaMDEstablish, harmonize, and continuously improve HF/UE processes, methodologies...SuggestedFull timeWorldwide$174k - $205k
...investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.ASSOCIATE...Suggested$189.3k - $351.5k
...assay design, analytical/clinical validation, bridging approaches, and regulatory pathways such as FDA PMA/IDE, EMA IVDR, and China NMPA.Extensive familiarity with both established diagnostic and emerging clinical platforms, including IHC, PCR, NGS, liquid biopsy, digital...SuggestedFull timeLocal areaRelocation package$320k - $340k
...in all aspects of GMP/GDP competence in meeting domestic and international regulatory requirements and guidelines (FDA, EMA, MHRA, NMPA, ICH, etc.).Lead the development and optimization of key processes, functional collaboration, transformational initiatives, and operational...SuggestedWork experience placementLocal area$55.8k - $103.6k
...staining. You strictly adhere to quality standards, maintaining equipment calibration and compliance with regulatory frameworks (OSHA, NMPA, FDA, QSR, ISO, and GMP). You perform and document transactions regarding the receipt, quarantine, storage, and disbursement of...SuggestedLocal areaRelocation package$117k - $137k
...investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.SENIOR...Suggested$400k
...investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Overview...Suggested$205k - $327.6k
...as Management Representative and primary interface with global regulatory authorities, including FDA, EU authorities, TGA, MHLW, and NMPA.Provide strategic oversight of the Quality Management System, regulatory submissions, post-market surveillance, product safety, and...SuggestedFull timeWork at officeImmediate startWork visa3 days per week$237.2k - $372.79k
...antibody‑based modalities, including immune‑related adverse event management.Exposure to health authority interactions (FDA, EMA, PMDA or NMPA) and registrational study design.Experience supporting partnered or alliance‑managed programs across regions.Peer‑reviewed...SuggestedMinimum wageWork at officeLocal areaRemote work- ...excellenceExperience transferring manufacturing lines to remote sites a strong plusExperience with submitting med devices to regulatory agency, like NMPA, a strong plusFluent in English and Mandarin (read/write) a strong plusBroad and deep understanding of Requirement Management and...SuggestedLocal areaRemote workWorldwideFlexible hours
$112k
...event reportability and submit timely reports to global regulatory bodies (e.g., US FDA 21 CFR 803, EU MDR/MDD, Health Canada, PMDA, NMPA) per mandated timelines. Perform trend analysis on PMS data, draw actionable conclusions, and present findings to leadership and...SuggestedImmediate startFlexible hoursAviso, LLC
Fremont, CA9 days ago$171.5k - $214.42k
...filing experience.Experience with ISS/ISE.Strong knowledge of CDISC standards for SDTM and ADaM.Strong knowledge of ICH, FDA, EMA, and NMPA regulations and guidelines.Exceptional interpersonal skills and problem-solving capabilities.Excellent oral and written...SuggestedContract workFlexible hours$302.01k - $390.83k
...applications and labeling for drug and diagnostic products.Maintain deep expertise in global diagnostic regulations (FDA, EU IVDR, PMDA, NMPA, etc.) and assess impact on development and registration activities.Monitor evolving regulatory landscape and translate into...Full timeFor contractorsWork at officeLocal areaFlexible hours$205.1k - $307.7k
...senior quality leader Serve as the subject matter expert for software quality in regulatory inspections (FDA, BSI, MDSAP, KFDA, PMDA, NMPA) and respond to observations requiring software quality remediation Represent Software Quality on the monthly Quality Council and...Full timeLocal area$2,941 - $3,676 per month
...equipment or hardware industry are preferred. Familiar with ODM/OEM business model for medical devices; basic knowledge of MDR, FDA and NMPA compliance requirements is a plus. Excellent communication, coordination, time management and problem-solving skills. Detail-...Full timeWork experience placementRelocationOverseas$200k - $240k
...secure software development practices.• Experience supporting global submissions involving software documentation for FDA, EU MDR, PMDA, NMPA, Health Canada, TGA, or equivalent authorities preferred.• Experience supporting design history files (DHF), software files, risk...$25.5 per hour
...tools. Navigates and understands the quality system and escalates issues. Accurately performs tasks in a regulated environment (OSHA, NMPA, FDA, etc.). Performs and documents all transactions and production instructions with accuracy related to the proper receipt,...Permanent employmentContract workLocal areaDay shift$145k - $160k
...clinical development programs. ~ Strong understanding of the drug development process and applicable regulatory requirements, including NMPA, FDA, and ICH-GCP guidelines. ~ Proven leadership skills with experience in project planning and execution, financial and risk...Contract workTemporary workRemote workWorldwideFlexible hours$200k - $235k
...investigational therapy not presently approved by any regulatory authority other than China's National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. This role...$258k - $320k
...control, deviation regulatory evaluation, etc.). Act as the primary CMC contact for interactions with health authorities (e.g., NMPA, CDE, FDA, EMA) on CMC-related issues, including leading pre-IND/NDA/BLA meetings and responses to regulatory questions. Lead regulatory...Work at officeWorldwideRelocation package$174k - $205k
...investigational therapy not presently approved by any regulatory authority other than China's National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Overview...Full time$150k - $230k
...lab operations and preparing for health authority inspections. ~ Strong understanding of global regulatory requirements (FDA, EMA, NMPA, ICH M10, E6). ~ Exceptional leadership and people management skills with a record of developing scientific talent and fostering...Full time$150k - $190k
...Compliance Provide oversight and guidance to ensure compliance with global GCP and GVP regulations, including FDA, EMA, MHRA, PMDA, NMPA, and ICH requirements. Support the development, implementation, and continuous improvement of the Clinical Quality Management...Full timeWork at office2 days per week3 days per week- ...botanicals and Traditional Chinese Medicine, including the USP Herbal Medicines Compendium, World Health Organization guidance, and China NMPA standards. Address regulatory matters involving botanical adulteration, safety data, ingredient identity, and traditional-use...Part timeFixed term contractWork at officeWorldwide10 hours per week
$150k - $230k
...PMA Support regulatory interactions and technical responses Contribute to global regulatory strategy including FDA, IVDR, and NMPA Support transition from RUO/LDT assays to IVD companion diagnostics Ensure diagnostic strategy supports precision medicine objectives...Full time$100k - $115k
...~ Strong working knowledge of FDA, EMA, and ICH GMP requirements; familiarity with additional health authority requirements (PMDA, NMPA, MHRA, etc.) preferred. Preferred APICS CPIM/CSCP or equivalent supply chain certification. Direct experience supporting...- ...Prior experience leading or contributing to regulatory interactions and submissions with global health authorities, including FDA, NMPA, and EMA. ~ Demonstrated leadership and people management experience with cross-functional teams. ~ Familiarity with clinical data...Temporary workInterim roleWork at officeRemote workFlexible hours
