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$100k - $145k
...global supply chain operations. Experience supporting EU MDR transitions or international regulatory submissions (Health Canada, PMDA, NMPA, ANVISA). Experience with electromechanical or software‑enabled medical devices (SaMD/SiMD). Working knowledge of cybersecurity...SuggestedContract workLocal areaImmediate startRemote workHome officeFlexible hours$190k - $260k
...requirements. Lead or contribute to the preparation of toxicology and safety pharmacology sections for INDs, CTAs, BLAs, NDAs, MAAs, NMPA submissions, briefing books, Investigator’s Brochures, and other regulatory documents. Serve as a key contributor to regulatory...SuggestedFull timeContract workMonday to FridayWeekend workAfternoon shift2 days per week- ...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....SuggestedFlexible hours
$150k - $185k
...regulatory interactions. Basic knowledge of ICH GCP, global clinical trial regulations, and regional requirements (FDA, EMA, MHRA, NMPA, PMDA, etc.). Experience with communication to cross-functional leaders and supporting alignment on regulatory strategy. Strong and...SuggestedLocal area- ...professionals to drive timely product approvals and ensure ongoing regulatory compliance in key markets such as USA (FDA), EU (MDR), China (NMPA), and more. Work cross-functionally with Clinical, Global Regulatory Affairs counterparts, and others to support innovation and...SuggestedContract workWork at office
- ...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,...SuggestedFor contractorsWork experience placementLocal areaShift work
- ...Responsibilities Prepare, review, and submit 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...SuggestedWork at officeLocal area
$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 officeWork visaRelocation package3 days per week$291k - $364k
...is an investigational therapy not approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, with additional offices in California, New Jersey, the UK, and Ireland. Overview Of Role...Suggested- ...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...Suggested3 days per week
$240k - $275k
...regulatory communications. Deep knowledge of ICH GCP, global clinical trial regulations, and regional requirements (FDA, EMA, MHRA, NMPA, PMDA, etc.). Proven experience influencing cross‑functional leaders and driving alignment on regulatory strategy. Outstanding...SuggestedLocal area- ...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...Suggested
$194k - $199k
...bevacizumab plus chemotherapy. Ivonescimab is an investigational therapy not presently approved by regulatory authorities other than China’s NMPA. Summit is headquartered in Miami, Florida, with additional offices in California, New Jersey, the UK, and Ireland. Hybrid: 4 days...SuggestedWork at office- ...early development through commercialization. Lead regulatory interactions with global health authorities including FDA, EMA, PMDA, and NMPA. Drive preparation for Health Authority meetings, briefing books, and regulatory correspondence. Lead the preparation and...SuggestedWorldwide
$92k - $138k
...software-based solutions and hardware. Advise cross-functional teams on regional regulatory requirements, including FDA (US), EU MDR, NMPA (China), PMDA (Japan), and TGA (Australia). Identify and recommend optimal regulatory pathways (e.g., 510(k), PMA, IDE, CE Mark, EU...SuggestedH1bWork at officeLocal areaImmediate startFlexible hours- ...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
$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...Full timeWork at officeWork visaRelocation package3 days per week$125k - $145k
...U.S. FDA regulations, submission processes, and quality system standards. Experience with global regulatory filings (e.g., CE Mark, NMPA) is a strong plus. Demonstrated ability to lead cross-functional projects and manage multiple priorities. Strong written and verbal...Full timeWork at officeLocal area- ...management. Ensure timely and compliant processing and reporting of ICSR submissions to health authorities (e.g., FDA, Health Canada, NMPA, etc.) and business partners. Oversee operational performance and workload distribution within the DSPUS organization and across...Local area
$148k - $170k
...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 contractorsWork experience placementFor subcontractorWork at office- ...regulatory strategy for oncology programs, spanning early development through commercialization. You will interact with FDA, EMA, PMDA, and NMPA, guiding global filings and regulatory strategy across cross‑functional teams. In this high‑visibility role, you will mentor teams,...Worldwide
- ...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
- ...connected embedded products. Knowledge of FDA cybersecurity guidance, IEC 62304, AAMI TIR57, NIST Cybersecurity Framework, EU MDR, NMPA, and other medical device cybersecurity standards. Experience with SAST, DAST, IAST, Software Composition Analysis (SCA), fuzz...Remote workRelocation
- ...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
- ...DSURs, safety reports, and clinical development documentation. Serve as the primary PV representative in interactions with FDA, NMPA, EMA, and other global health authorities, including Type B/C meetings, Health Authority safety queries, and pharmacovigilance inspections...Temporary workFor contractorsWork at officeRemote workFlexible hours
- ...with Lundbeck policies, standard operating procedures, and applicable China laws and regulations. 5. Monitor and interpret NMPA/CDE regulatory requirements, policy changes, and competitor regulatory information; provide timely assessment and recommendations to...Local area
$130k - $160k
...support CDx regulatory strategy and submissions (e.g., IND/IDE, PMA/IVD). Ensure compliance with global regulatory requirements (FDA, NMPA, IVDR). Support bridging strategies from RUO/LDT to IVD CDx and contribute to regulatory interactions. Drive alignment with...Full time$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- ...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,...
- ...and solutions. Experience with multi-regional GMP regulatory frameworks across the US (FDA), EU (EMA), UK (MHRA), and/or China (NMPA). Ability to travel up to 15% of the time, both domestic and international. The range provided is based on what we believe is...Contract workFlexible hours