Regulatory Affairs Manager

Karwell Technologies

Irvine, CA

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JOB DETAILS

SKILLS

Artificial Intelligence (AI), Biochemistry, Bioengineering, Biology, Clinical Practices/Protocols, Coaching, Communication Skills, Continuous Improvement, Cross-Functional, Current Good Manufacturing Practice (cGMP), Data Collection, Environmental Impact, FDA (Food and Drug Administration), ISO (International Organization for Standardization), Import/Export, International Electro-Technical Commission (IEC), Interpret Regulations, Maintain Compliance, Medical Equipment, Operational Strategy, Performance Reviews, Policy Implementation, Presentation/Verbal Skills, Product Lifecycle Management, Promotional Programs, Quality Control, Regulations, Regulatory Requirements, Software Administration, Strategic Planning, Technical Writing, Time Management, Ultrasound, Writing Skills

LOCATION

Irvine, CA

POSTED

30+ days ago

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.

Regulatory Affairs Manager

Karwell Technologies

Irvine, CA

About the Company

Karwell Technologies

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