Job-ID31508263Reference25-04457 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.
A well-established San Francisco-based law firm is seeking Document Review Attorneys to assist with a high-volume review project. This is a contract role ideal for attorneys who are detail-oriented and experienced with reviewing large sets of documents for relevance, privilege...
...Job Description Job Description Job Summary: Supervisors oversee the manufacturing process by leading staff and production processes to ensure the production of quality product in an efficient and safe manner. Essential Functions Maintains staff by assisting...
...439Reference25-02134 Responsibilities: Contributes to the FDA regulatory submission process; may aid in authoring and/or publishing electronic... ...equivalent). A minimum of 3 years' experience in Regulatory Affairs Advanced experience in the areas that may include preparation...
...Job Description Job Description HealthYes is speaking with Hospitalists interested in locum tenens coverage near Savannah, Georgia. These are active inpatient coverage needs with consistent scheduling and strong clinical support. Opportunity Overview Inpatient...
84 months of experience in platform engineering, DevOps, or cloud infrastructure, including designing and operating CI/CD pipelines in production... ...mentorship to mid-level engineers Bachelor's Degree Google Cloud Professional DevOps Engineer, Terraform Associate (HashiCorp...