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- ...Regulatory Affairs Specialist (NMPA) It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally...SuggestedFor contractorsLocal areaWorldwide
- ...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
$200k - $250k
...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...Suggested$139k - $160k
...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...Suggested$95k - $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...Suggested$148k - $174k
...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...SuggestedShift work$128.52k - $205.63k
..., such as CE Marking and product registrations, clinical evaluations in accordance with MDD Annex X, ISO 13485 and ISO 14155, China NMPA, Canadian CMDCAS, Japan JPAL, compliance with FDA’s guidance documents, and including requirements that are relevant to the overall...SuggestedFull timeWork at officeImmediate startRelocation package3 days per week$180k - $200k
...are embedded into all business processes. Lead global readiness and response for regulatory changes (e.g.,MoCRA, EU updates, China NMPA reforms). Oversee governance structures, including quality KPIs, audit programs, risk registers, and compliance reporting. Quality...SuggestedTemporary workVisa sponsorshipShift work$180k - $210k
...7, and HARMONi-GI3. Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s NMPA. Summit is headquartered in Miami, Florida, with additional offices in California, New Jersey, the UK, and Ireland. Role and Responsibilities...SuggestedWork at office3 days per week$134k - $231.15k
...is maintained in compliance with ISO 13485 and ISO 14971 processes. Stay current with global regulatory changes (EU MDR, FDA, China NMPA, etc.) impacting EMC and safety compliance and communicate updates to internal stakeholders. Support regulatory submissions and...SuggestedTemporary workLocal areaFlexible hours- ...deviations. \* \*\*Regulatory Compliance:\*\* Ensure all clinical trial activities comply with local regulatory requirements (e.g., NMPA), ethical guidelines, and Lilly's Standard Operating Procedures (SOPs). Prepare and submit necessary regulatory documents. \* \*\*Team...SuggestedContract workWork at officeLocal area
$43.9k - $81.5k
...tools.* 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,...SuggestedLocal areaRelocation packageWeekend workAfternoon shift- ...from other regulatory authorities. Experience with submissions including human factors data outside the US, such as EMA, MHRA, PMDA, NMPA, etc. Enjoy managing people, focusing on their development. Possess a wide variety of human factors skills, such as ethnography,...SuggestedLocal area
- ...presentation and influencing skills. Preferred Skills: PMP certification or equivalent. Knowledge of global regulatory (FDA, Anvisa, NMPA, MDR) and quality requirements (ISO, GB, JISC etc.). A six‑sigma design and development background. Has successfully launched...SuggestedWork at officeRemote work
- ...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
- ...Continual evaluation of literature and external environment to stay up to date on the latest relevant regulatory guidance documents (e.g., NMPA, ICH, FDA, EMA), technologies, methodologies, software that has potential application to the functional area, and cross-functional...For contractorsInternshipLocal area
- .... Be skilled at reading and understanding of GMP documentation. Must be trained or have experience to meet the GMP regulations of NMPA, EMA and FDA, etc. High awareness of confidentiality and responsibility. Detail oriented and effective time management. Be able to...Full timeWork at office
$128.52k - $205.63k
...including CE Marking, product registrations, clinical evaluations (in accordance with MDD Annex X), ISO 13485 and ISO 14155, China NMPA, Canadian CMDCAS, Japan JPAL, and FDA guidance documents applicable to Philips Ultrasound priorities globally. Represent Philips Ultrasound...Full timeWork at officeRelocation package3 days per week$165.2k - $202k
...Substance sections (S.1-S.7). Ensure alignment with ICH M4Q, ICH Q7-Q11, and applicable global requirements (FDA, EMA, Health Canada, PMDA, NMPA). Coordinate inputs from internal SMEs (PD, AD, Manufacturing, Engineering, QC, QA) and external writers/consultants. Ensure...- ...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 &...Work at officeRemote workShift work
- ...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
$20 - $40 per hour
...publication of cybersecurity risk management reports. Assist with documentation for regulatory submissions including US FDA, EU MDR, China NMPA and other international regulatory bodies. Support regulatory assessments of Align Technology’s processes against global...Internship$175k - $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 Of...Contract work$150k - $230k
..., and 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- ...Anforderungen (MDR, relevante internationale Verordnungen, Richtlinien, Normen) Erfahrung im Bereich internationaler Zulassungen (z.B. FDA, NMPA, ANVISA, MOHW) ist ein Plus Sehr gute Kenntnisse von QM-Systemen nach ISO 13485 sowie idealerweise MDSAP Stark ausgeprägte...Flexible hours
$90k - $140k
...preclinical biology, translational science, and clinical biomarker implementation, including support for global regulatory strategies (FDA/NMPA) and CDx co‑development. This position is full‑time onsite at our Redmond, WA location. Key Responsibilities IHC Assay Development...Full time- ...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 &...Shift work
$127.5k - $236.7k
...of clinical programs. Understands, applies good knowledge of, and ensures adherence to ICH-GCP, IVDD/IVDR, MDR, SaMD, FDA, Bfarm, NMPA regulations, etc across the respective programs to ensure objectives are met in support of CDMA and/or Diagnostics goals. Experience...Local areaRelocation package- ...that study records for GLP studies are archived upon completion of the study. • May need to interact with regulatory bodies (i.e. FDA, NMPA, ANSM, etc) • Prepares protocol submissions for IACUC review and responds to committee comments/questions as necessary. • Interacts...For subcontractorWork at office
$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