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- ...tools. Navigate and understand the quality system and escalate 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,...Suggested
$200k
...competence and excellent communication skills, both oral and written. Successfully led Phase III regulatory submissions to FDA, EMA, NMPA, PMDA, etc. Able to identify data or analytical issues, and assist with providing solutions by either applying own skills and...SuggestedSystImmune
Redmond, WA4 hours ago$197.3k - $394.7k
...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 biocompatibility...SuggestedFull time- ...scientific literature search and interpretation. Familiarity with IVD product development processes and regulatory requirements (NMPA, FDA, IVDR) preferred. Experience ~ Minimum of 2-3 years of laboratory or R&D experience in the IVD industry preferred. Benefits...SuggestedFlexible hours
- ...~Navigates and understands the quality system and escalate 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, quarantine...Suggested
$117k
...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...SuggestedWork at officeSummit Therapeutics, Inc.
Palo Alto, CA9 days ago$108k - $176k
...other regulatory authorities. Have experience with submissions including human factors data outside the US, such as EMA, MHRA, PMDA, NMPA, etc. Have experience in and enjoy managing people, focusing on their development. Have experience with a wide variety of...SuggestedLocal areaMonday to Friday$79.7k
...environment. Knowledge of GLP regulations is desirable. Experience with regulatory body submissions, including FDA, EU MDR, PMDA, or NMPA. Proficiency with Microsoft Word, Excel, PowerPoint, Minitab, and other data analysis tools. Requisition ID:618524 Minimum Salary...SuggestedHourly payWork at officeLocal areaWorldwideRelocation packageShift work3 days per week- ...of regulatory dossiers, including FDA 510(k), De Novo, EU MDR Technical Documentation, Health Canada license applications, ANVISA, NMPA, CDSCO, TGA, and other international filings. Develop and execute regulatory strategies for new product development, AI/ML-enabled...SuggestedFull timeTemporary workPrivate practiceWorldwideFlexible hours
$184k - $230k
...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...SuggestedWork at officeLocal area$118k - $165k
...certification. Regulatory Knowledge on US: FDA, FCC; EU: MDR, Radio Equipment Directive, Low Voltage, EMC; Canada, Asia: Health Canada, NMPA; Wireless/telecom certifications; Supply‑chain sensor regulations. Experience with global standards such as ISO 13485, ISO 14971,...SuggestedTemporary workVisa sponsorshipFlexible hours$139k - $163k
...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...SuggestedFull time- ...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 experience placementWork at officeRelocationFlexible hours3 days per week
$142.4k - $224.1k
...Under the guidance of the CQO Lead, the CQOM may be assigned as Point of Contact for a specific area of regulations (e.g. FDA, EMA, NMPA, etc.). As such, the COM is responsible for monitoring, interpreting and communicating key regulatory developments within CQO. Work...SuggestedRemote jobFor contractorsWork at officeLocal areaWorldwideRelocationVisa sponsorshipFlexible hoursShift work3 days per week$201.17k - $321.88k
...provide recommendations. Coordinates and leads audit activities with all global regulatory agencies (e.g. FDA, Notified Bodies, PMDA, NMPA etc.) Creates and maintains Compliance department internal methodology and procedures that comply with applicable domestic and...SuggestedFull timeLocal areaRemote workWorldwide$96k - $144k
...Familiarity with global human factors guidance and regulatory standards (e.g., IEC 62366, ANSI/AAMI HE75, FDA Human Factors Guidance, NMPA, and other international equivalents). Experience conducting and moderating formative and summative usability evaluations....Work at officeLocal areaFlexible hours$90k - $130k
...data integrity, traceability, and compliance Support internal QA audits, external audits, and regulatory inspections (e.g., FDA, EMA, NMPA) Contribute to IND, CTA, and other regulatory submission documents related to bioanalysis and clinical pharmacology Translational &...- ...processing and primary staining. ~1 year experience with operating laboratory or manufacturing equipment ~ Tissue Sectioning and Staining ~ Experience working in regulated environment (OSHA, NMPA, FDA, etc) ~ GMP ~ Google Suite (gMail, gSheets, gDoc, etc) ~ SAP...Shift workAfternoon shift
- ...regulatory submissions to medical device regulatory bodies a plus; e.g., FDA, Health Canada, ANVISA/INMETRO, EU NB, MHRA, Swissmedic, NMPA, PMDA, MFDS, and TGA. Experience with software‑driven and electro‑mechanical medical devices a plus. Strong knowledge of US and...Worldwide
$244.11k - $295.81k
...Mastery, but not limited to GCP, GLP, CLIA, HIPAA, 21 CFR Parts 11, 312, 812, 820, ISO 13485, ISO 14971, EU IVDR, CMDR, TGA, PMDA, NMPA, and ICH guidelines to ensure compliance and quality across investigational use only assay programs. ~ Communication & Collaboration...Hourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$142k - $201k
...knowledge of scientific research methodology, device development process, GCP, ICH guidelines and Global (US FDA, EU MDR, Japan PMDA, China NMPA) regulations. Experience working in a cross functional, collaborative environment and comfortable interacting with R&D engineers,...Remote work$137.1k
...technical and business process solutions to complex problems ~ Knowledge of global medical device regulatory requirements (FDA, Anvisa, NMPA, MDR) and quality standards (ISO, GB, JISC) ~ Complete understanding of medical device project management principles, theories &...Hourly payWork at officeRemote workShift workBD
Lakewood, CO27 days ago$137.1k
...technical and business process solutions to complex problems ~ Knowledge of global medical device regulatory requirements (FDA, Anvisa, NMPA, MDR) and quality standards (ISO, GB, JISC) ~ Complete understanding of medical device project management principles, theories &...Hourly payWork at officeRemote workShift workBD
Lakewood, CO27 days ago$150k - $200k
...as a statistical programming team leader or manager Fluency in English and Chinese Strong knowledge of relevant regulatory (FDA, NMPA, EMA, PMDA, etc.) and data submission guidelines Strong understanding of drug development, including knowledge of interfaces and interdependencies...Contract workWorldwide- ...optimization services, data analytics, creative & marketing, among others. Will work closely with various trade associations, including NMPA (National Music Publishers’ Association, various societies, and IFPI, among others. WHAT SKILLS AND EXPERIENCE ARE WE LOOKING...Full time
$153k - $180k
...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 timeOverseasFlexible hours$90k - $140k
...Quality Collaboration Work closely with Regulatory Affairs and Quality Assurance to ensure compliance with: FDA CDx guidance (US) NMPA/CDE requirements (China), where applicable IVDR (EU), as relevant Support preparation of regulatory documentation, including: IDE...$231k - $289k
...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$260k - $315k
...SAS (Base, Macro, STAT, GRAPH, SQL); proficiency in R or Python strongly preferred. Comprehensive understanding of FDA, EMA, PMDA, NMPA, ICH E3/E9, and global regulations and guidelines, including eCTD, define.xml, and reviewers’ guide deliverables. Deep...$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
