Join to apply for the Regulatory Affairs Manager role at Katalyst CRO 3 days ago Be among the first 25 applicants Join to apply for the Regulatory Affairs Manager role at Katalyst CRO In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key markets such as USA (FDA), EU (MDR), China (NMPA), and more. You will work cross-functionally with Clinical, Global Regulatory Affairs. counterparts, and others to support innovation and expand market access for our advanced ultrasound technologies and solutions. Develop and implement global regulatory strategies for new product registrations, software updates (including AI-powered features) and product lifecycle management. Lead preparation and submission of technical documentation and regulatory dossiers to authorities such as NMPA, FDA, EU notified bodies, and other international regulatory agencies. Oversee and coach a team of regulatory professionals to support both strategic and operational objectives. Interpret and apply regulatory requirements for medical devices (including IEC/ISO standards, NMPA, FDA 510(k), MDR, etc.). Define and execute submission strategies to meet timelines and business goals. Act as liaison to regulatory authorities and internal/external stakeholders; manage interactions and responses during submission review. Monitor changes in international regulatory environments and communicate impacts to internal teams. Represent the company in industry groups or regulatory associations, where appropriate. Support training and knowledge-sharing on country-specific regulatory requirements within the organization. Responsibilities In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key markets such as USA (FDA), EU (MDR), China (NMPA), and more. You will work cross-functionally with Clinical, Global Regulatory Affairs. counterparts, and others to support innovation and expand market access for our advanced ultrasound technologies and solutions. Develop and implement global regulatory strategies for new product registrations, software updates (including AI-powered features) and product lifecycle management. Lead preparation and submission of technical documentation and regulatory dossiers to authorities such as NMPA, FDA, EU notified bodies, and other international regulatory agencies. Oversee and coach a team of regulatory professionals to support both strategic and operational objectives. Interpret and apply regulatory requirements for medical devices (including IEC/ISO standards, NMPA, FDA 510(k), MDR, etc.). Define and execute submission strategies to meet timelines and business goals. Act as liaison to regulatory authorities and internal/external stakeholders; manage interactions and responses during submission review. Monitor changes in international regulatory environments and communicate impacts to internal teams. Represent the company in industry groups or regulatory associations, where appropriate. Support training and knowledge-sharing on country-specific regulatory requirements within the organization. Requirements BS/MS degree or equivalent experience required. Expertise with global medical device regulations and registration processes, especially USA 510(k) and EU MDR. Superior presentation skills when communicating with all levels of the organization, business partners, and external sources. Ability to work with evolving technologies, systems, and global teams in a fast-paced, matrixed environment. Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations. Seniority level Seniority level Associate Employment type Employment type Contract Job function Job function Legal Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new Regulatory Affairs Manager jobs in Omaha, NE . Omaha, NE $41,800.00-$57,400.00 1 week ago Omaha, NE $100,500.00-$173,250.00 1 month ago Omaha, NE $69,000.00-$113,850.00 3 months ago Omaha, NE $69,000.00-$113,850.00 3 months ago Omaha, NE $105,120.00-$128,480.00 2 weeks ago Manager, Compliance and Integrity Engineering Omaha, NE $120,000.00-$170,000.00 2 days ago Omaha, NE $117,000.00-$187,200.00 1 week ago Risk & Compliance Senior Associate - Crop Council Bluffs, IA $64,000.00-$96,000.00 3 weeks ago Sr Manager Liquidity Regulatory Reporting Environmental Compliance Engineer/Project Manager/Scientist Manager, International Compliance & Reporting Services Omaha, NE $68,696.00-$114,313.00 3 weeks ago Council Bluffs, IA $80,000.00-$90,000.00 4 days ago Air Quality Project Manager - Environmental Services (Multiple Locations) Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr Katalyst CRO
...Position Overview: We are seeking a dynamic Corporate Recruiter to join our human resources team and drive talent acquisition for our organization. This role focuses on identifying, attracting, and hiring top-tier candidates to support our corporate growth, with an emphasis...
...Job Description Job Description Looking for AMAZING school-age teachers (Lead and Assistant) who want to make a difference in children... ...highly creative and energetic activities before and/or after school and on school closure days. Balance enrichment, creative...
...Immediately ~ Set Schedules ~ Opportunity for Advancement ~ Full Benefits ~ Employee Meal We are currently hiring for Baristas to work at our restaraunts inside the Minneapolis Airport Here are a few things you can expect when you join our team as a...
...maintaining daily census records, entering all intake and admission data into database, handling intake calls and verifying insurance... ...Job Duties/Responsibilities Ensure written and computer entries of intake calls, assessments, and admissions are accurate and thorough...
...Job Description Job Description At The UPS Store, the Sales Associate role is more than just a job, it's an opportunity. In addition... ...person, responsible for the operation of the store, who invests time in his or her employees, teaching them important business skills...