Regulatory Affairs Manager

Katalyst CRO; Irvine (CA); On-site; USD 80,000 - 120,000; Full time

Job summary

Katalyst CRO is seeking a Regulatory Affairs professional based in Irvine, California. The role involves leading regulatory strategies, product submissions, and managing a skilled team to ensure compliance in key markets including the USA and EU. Candidates should have a Bachelor's or Master's in a relevant scientific field and 5 years of experience in medical device regulatory affairs. Strong communication skills and the ability to navigate regulatory environments are essential. Experience with FDA submissions is preferred.

Qualifications

• 5 years of medical device IVD Regulatory Affairs experience including 510(k) or PMA submissions.
• Proficient in regulatory strategy creation and quality systems.
• Continuous improvement mindset familiar with balancing Quality and efficiency.

Responsibilities

• Lead regulatory strategies and product submissions for timely approvals.
• Develop global regulatory strategies for new product registrations.
• Monitor changes in international regulatory environments.

Skills

Regulatory strategy creation

Communication with regulatory agencies

Regulatory review of marketing materials

Scientific presentation skills

Education

Bachelor's or Master's in biology, chemistry, bio-engineering or related scientific area

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
• 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.