- Philips (New Kensington, PA)
- …submissions, pre-sub documents, EUMDR tech files, and will contribute to international regulatory submissions. + Participate in strategic product development, ... familiarity with FDA, EU MDR, Health Canada, and other relevant international regulatory standards and regulations. + You have knowledge and understanding of… more
- Olympus Corporation of the Americas (Westborough, MA)
- …to regulatory or auditor inquiries as directed. + Interface with International Regulatory Affairs Team and drive preparation of dossiers for registration ... Life at Olympus: https://www.olympusamerica.com/careers . **Job Description** The Sr. Regulatory Affairs (RA) Specialist II Digital Health supports ...on for other international markets such as Japan, Middle East and Africa,… more
- Takeda Pharmaceuticals (Boston, MA)
- …to data issues, ensuring timely resolution. + Maintain awareness of evolving international regulatory requirements (eg, IDMP, SPOR, XEVMPD, eCTD, ePI, PQ/CMC, ... is true to the best of my knowledge. **Job Description** **Summary:** The Regulatory Data Steward plays a key role in ensuring the quality, integrity, and… more
- Pentax Medical (Montvale, NJ)
- …for a FDA regulated employer + Thorough understanding of domestic and international regulatory requirements for medical devices + Experience with reusable ... compatibility and compliance with customs documentation requirements. + Support International product registrations. Requirements of Senior Regulatory Affairs… more
- Terumo Neuro (Aliso Viejo, CA)
- …activities focused on US/EU/Canada and ensuring compliance to FDA and international regulatory agency requirements for Neurovascular and Peripheral devices. ... impact of product changes on US, EU, Canada, and/or international regulatory strategy/submissions, across product lines per MicroVention procedures.… more
- Amazon (San Francisco, CA)
- …meet all relevant regulations. This role requires deep technical knowledge of international regulatory standards for RF, EMC, BLE, Zigbee, Antenna Systems, ... and will ensure our products conform with North American and worldwide regulatory standards and compliance requirements. Your expertise in wireless radio technology,… more
- Ralliant (Raleigh, NC)
- …in good standing + 6-8 years of legal experience with deep expertise in international regulatory compliance. + Strong background in a highly regulated industry ... The ideal candidate is a licensed attorney with deep experience in international compliance and regulatory matters, capable of independently managing legal… more
- Lilly (Indianapolis, IN)
- …and working across functional and geographical boundaries.** **Knowledge of the international regulatory framework.** **Demonstrated ability to identify root ... to make life better for people around the world. **The purpose of the CMC Regulatory Quality Advisor role is to be the quality expert for their given area of… more
- Edwards Lifesciences (Irvine, CA)
- …teams help guide our innovative technologies through complex domestic and international regulatory environments. Working in partnership with external government ... and regulatory authorities, and alongside diverse internal stakeholders, your close...**How you will make an impact:** + Represent the regulatory function on manufacturing and product development teams to… more
- ThermoFisher Scientific (Greenville, NC)
- …is responsible for managing global labeling activities and ensuring compliance with international regulatory standards. This role coordinates all aspects of ... of labeling documents. The position requires strong organizational, technical, and regulatory expertise to manage complex global labeling operations within a… more