Unknown Company

Regulatory Affairs Manager

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irvine, ca • Posted 1 weeks ago
Onsite Full Time Management & Operations

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

  • Bachelor's degree and/or master's in biology chemistry bio-engineering or related scientific area
  • 5 years of medical device IVD Regulatory Affairs experience to include either 510(k) or PMA Notified Body (NB) submissions
  • Preference would be a former regulatory agency reviewer or staff (e.g FDA submission reviewer)
  • Proficient in the aspects of regulatory strategy creation design control cGMP/Quality Systems and import/export requirements
  • Experience in direct communication with regulatory agencies
  • Regulatory review experience of promotional marketing materials presses releases labelling etc
  • Strong oral and written communication skills as well as the ability to provide scientific presentations!
  • Ability to compile data and summarize results
  • Continuous improvement minded familiar with balancing Quality and the need for efficiency.

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