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$140k - $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...SuggestedWork at office$237k - $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. We are...Suggested$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. Overview...SuggestedWork at office$95.23k
...Optimization (ECO) and Value of Electricity programs for Minnkota Power Cooperative (Minnkota) and Northern Municipal Power Agency (NMPA). This position is responsible for providing services, expertise, and support to the member cooperatives and municipal systems to help...SuggestedWork at officeFlexible hoursNight shift$174k - $204.5k
...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...SuggestedContract work$90k - $130k
...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...Suggested$35 - $40 per hour
...testing, heavy metals, pesticide limits). Navigate TCM-specific regulations (e.g., USP Herbal Compendium, WHO guidelines, China NMPA standards). Address challenges in botanical adulteration, safety data, and traditional use claims. Education and Experience Requirements...SuggestedPart timeFixed term contractHuisong Pharmaceuticals
Santa Ana, CA5 days 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$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, WA20 days ago- ...~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
- ...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
$135.5k - $150k
...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 timeInterim roleOverseas$120.49k - $192.78k
..., 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 startWork visaRelocation package3 days per week- ...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
$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$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...Full timeLocal areaRemote workWorldwide$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$111.75k - $167.5k
...place special emphasis on IEC62366 – 1, the FDA’s guidance Applying Human Factors and Usability Engineering to Medical Devices, and the NMPA Guidelines for the review of medical device usability engineering registration. You will maintain a network of external...Work at officeWorldwideFlexible hours- ...program needs, and may evolve as development plans progress. Key Responsibilities ~Provide regulatory guidance related to China (NMPA) requirements for IVD, IUO, and software-enabled products ~Advise on regulatory strategy to ensure alignment during product development...Contract workRemote work
$200k - $300k
...global regulatory strategies to achieve rapid approvals for investigational and marketing plans from agencies such as FDA, EMA, PMDA, NMPA (CHN) Perform research to drive development of regulatory strategy for the assigned clinical development program Lead and drive...Full time$150k - $200k
...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...Full timeContract workWorldwide$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- ...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...Full timeTemporary workPrivate practiceWorldwideFlexible 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:...Full time- ...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...Worldwide
$150k - $230k
...Experience working with automated IHC platforms and external diagnostic partners Familiarity with global CDx regulations (EU IVDR, China NMPA) Leadership Competencies Strategic decision-making with execution awareness Clear, confident FDA-facing communication...Full time- ...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
Aequor Technologies
Tucson, AZ16 hours ago - ...site management, biometrics, and data integrity. Act as a key clinical resource in interactions with regulatory agencies (FDA, EMA, NMPA), ensuring adherence to regulatory requirements in both US and China. Team Development & Collaboration Build and lead a high-...Permanent employmentFull timeContract workTemporary workLocal areaWorldwideFlexible hours
Legend Biotech US
Somerset, NJ16 hours ago $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...Contract workSummit Therapeutics Sub, Inc.
Menlo Park, CA2 days ago$186k - $233k
...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....Summit Therapeutics Sub, Inc.
Menlo Park, CA4 days ago
