Bachelor's or master's degree in biology, chemistry, bio-engineering, or related field
5+ years of medical device IVD Regulatory Affairs experience, including 510(k) or PMA submissions
Preference for former regulatory agency staff (e.g., FDA reviewer)
Proficient in regulatory strategy, design control, cGMP/Quality Systems, and import/export regulations
Experience communicating directly with regulatory agencies
Experience reviewing promotional marketing materials and labeling
Strong oral and written communication skills, capable of scientific presentations
Data compilation and summarization proficiency
Responsibilities
Lead regulatory strategies and product submissions to drive timely approvals
Collaborate cross-functionally with clinical and global counterparts to expand market access
Develop global regulatory strategies for new product registrations and lifecycle management
Prepare and submit technical documentation and regulatory dossiers to authorities
Coach and oversee a team of regulatory professionals to achieve objectives
Interpret and apply regulatory standards for medical devices
Define and execute submission strategies to align with business goals
Act as a liaison to regulatory authorities, managing submissions and interactions
Monitor and communicate changes in international regulations to internal teams
Represent the company in industry groups or regulatory associations
Benefits
Opportunity to lead in a critical role for product approvals
Access to advanced ultrasound technologies and solutions
Collaborative cross-functional work environment
Professional development through team coaching and mentoring
Chance to influence regulatory strategy and market access
Full Job Description
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
ct 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
