Job-ID31683224Reference26-00010 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.
ResponsibilitiesHelper Responsibilities: Job DescriptionResponsibilities include assisting with loading, unloading and yard clean-up. QualificationsHelper QualificationsHeavy lifting OverviewHelperWe are a Large Corporate Industry Leader in Building Supplies Employing over...
...Position: Landscape Design & Sales RepresentativeLocation: Honeoye Falls, NYHours: Full-TimeProjected Annual Earnings: $82,600 - $150,000+. This position offers a base salary plus performance-based sales commissions. Projected earnings are based on sales performance...
...The Certified Nursing Assistant will provide routine individualized healthcare based on a care plan set by LPN to the hopsice elderly, convalescents... ...of Caregiving experience (preferred) Valid Virginia CNA licencs Driver's License, Car Insurance and Car Registration...
...Job Description Job Description Certified Occupational Therapy Assistant (COTA) PRN Location: Olean, NY Schedule: PRN 19 hours per week and/or as needed Premier Therapy is seeking a PRN Certified Occupational Therapy Assistant (COTA) to join our therapy...
...building owners, contractors, manufacturers, and design professionals with a wide range of engineering and architectural issues.Your RoleAs an Architectural Intern in our Forensics Practice, you will gain hands-on experience investigating building envelope failures,...