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$172k - $344k
...compliance with ISO 10993 and applicable global regulatory guidance.Provide expert input for regulatory submissions (IDE, PMA, 510(k), CE, NMPA, etc.) and represent the function during audits and agency interactions.Maintain strong awareness of evolving global...SuggestedShift work- ...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
- ...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
$99.3k - $198.7k
...manufacturing or other similarly regulated environment. Required knowledge of regulations and standards including MDD, MDSAP, MDR, NMPA, applicable U.S. Code of Federal Regulations (CFR 803, 806, and 820), and ISO 13485 and 14971.Five (5) years in management capacity....Suggested$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- ...procedures, developing strategies, authoring, reviewing, and supporting global registrations, including Premarket Notifications, China NMPA Registrations, Technical Documentation for CE Marking, and technical packages. The Sr. Specialist ensures timely and high-quality...SuggestedTemporary workWork at officeRelocationFlexible hours3 days per week
$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$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$294k - $367k
...organization, overseeing CMC regulatory activities and ensuring alignment with health authority expectations globally (FDA, EMA, PMDA, NMPA, etc.). The role requires expertise in small molecule pharmaceutical development and manufacturing, an understanding of the oncology...SuggestedFull timeLocal area$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$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- ...approvals, UDI requirements, or product traceability. Understanding FDA regulated products and global equivalents (EU MDR, UKCA, PMDA, NMPA, ANVISA, etc.) Governance, Policy, and Risk Management: establish and maintain global policies covering: HS classification,...SuggestedLocal areaFlexible hours
$94k - $150k
...include coordinating and preparing regulatory submission documents for agencies such as the FDA, Health Canada, EU Competent Authorities, NMPA, and ANVISA, and offering strategic guidance on clinical studies and evaluations.Your role:Act as an ambassador of Philips values...SuggestedFull timeWork at officeImmediate startWork visaRelocation package3 days per week$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...SuggestedFull timeLocal area- ...year experience with operating laboratory or manufacturing equipment. Tissue Sectioning and Staining. Experience working in regulated environment (OSHA, NMPA, FDA, etc). Regards, Aequor Technologies LLC 377 Hoes Lane, Suite 300 Piscataway, NJ 08854 #J-18808-Ljbffr AequorSuggestedContract workAfternoon shift
- ...writing Expertise in medical device applicable regulations including but not limited to, MEDDEV 2.7.1, MDR, PMA, 510K, IDE and China (NMPA) Experience in the application of therapeutic and device knowledge to develop CERs Strong experience in conducting literature...
$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$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...Minimum wageWork at officeLocal areaRemote work$217k - $271k
...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 of...Contract workFor contractorsFor subcontractorWork at office$203k - $253k
...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 of...Contract work$109.02k - $147.5k
...PK) assays, ensuring adherence to sponsor requirements and current regulatory guidance on bioanalytical assays (e.g. FDA, ICH, EMEA, NMPA) Leads the transfer and validation of PK assays at external CROs using ligand-binding, ELISA, ECL, LC-MS/MS and hybrid methodologies...Contract workFlexible hours- ...documentation, including product registration dossiers, SOPs, system documents, and production standards. Support regulatory submissions for NMPA, FDA, IVDR, or other global compliance frameworks. Assist in product upgrades, process improvements, method validation, and...InternshipFlexible hours
$190k - $237k
...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. Our M ission...- ...input and guidance to cross-functional partners regulatory documentation for medical device approvals in compliance with EU MDR, MDSAP, NMPA, TGA, ANVISA, ANMAT, and other relevant regulatory bodies and/or Distributors. Develop regulatory strategies for new product...Work at officeLocal areaWorldwide
- ...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,...For contractorsWork experience placementLocal areaShift work
$10 - $20 per hour
...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 of...Contract work$205k - $240k
...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...$200k - $240k
...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 of...- ...Software‑as‑a‑Medical‑Device (SaMD) and AI/ML‑specific submission experience OUS regulatory strategy: CE Mark / EU MDR, PMDA (Japan), NMPA (China), Health Canada Real‑world evidence and post‑market surveillance design Prior startup experience where you built the...Permanent employmentRemote work
- ...evidence‐based, and traceable outputs, including integration into IFU and regulatory submissions (e.g., 510k, Technical Documentation, NMPA etc).* Drives program risk management and knowledge sharing to optimize execution and evidence generation, and bridges regional and...3 days per week