Senior Regulatory Affairs Associate

QuidelOrtho

2d • Remote

About The Position

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. At QuidelOrtho, we’re advancing the power of diagnostics for a healthier future for all. Join our mission as our next The Senior Regulatory Affairs Associate. This role provides strategic and tactical regulatory leadership for the QuidelOrtho product portfolio, with a dedicated focus on Complex Systems. This includes Physical IVD Instrumentation, Embedded Software, Software as a Medical Device (SaMD), Laboratory Automation, and Connectivity/Informatics solutions. The successful candidate will lead regulatory impact assessments for design changes, author high-quality global pre-market submissions, and ensure compliance with evolving Cybersecurity (Section 524B) and global Digital Health mandates. This role acts as a critical bridge between Commercial Marketing, Technical R&D teams, and Global Regulatory Bodies to ensure seamless market access and total lifecycle compliance. This role is remote based in California.

Requirements

• Required: Bachelor’s degree in a Scientific, Engineering, or Bio-Medical discipline.
• Minimum of 5–8 years of progressive experience in Medical Device or IVD industry.
• Design Change Expertise: 3–5 years of direct experience performing Regulatory Impact Assessments for complex system modifications. Examples include evaluating changes related to Software Architecture (refactoring/OS migration), Hardware Obsolescence (component end-of-life), Manufacturing Process Transfers, CAPA remediations, Reliability/Performance enhancements, etc. Must be proficient in documenting "Letter to File" rationales and authoring robust technical justifications that ensure defensibility and inspection readiness.
• Technical Specialization: 3–5 years of experience with IVD Instrumentation and Software. Proven track record authoring instrument and software-centric 510(k)/PMA sections, including Risk Management (Traceability), Software V&V, Human Factors/Usability, Off-The-Shelf (OTS) Software, Interoperability, and cybersecurity.
• Cybersecurity Proficiency: Practical knowledge of 2023/2025 FDA Cybersecurity Guidance updates. Significant advantage for candidates with direct experience authoring and technical editing of Cybersecurity submission components, including System Threat Models (e.g., STRIDE/HEART), Security Architecture Views, and Software Bill of Materials (SBOM). The ideal candidate can translate engineering penetration testing and vulnerability scan data into a cohesive Cybersecurity Management Plan that meets FDA 510(k) 'Cyber Device' statutory requirements.
• Standards Knowledge: Firm grasp of IEC 62304 (Software Lifecycle), ISO 14971 (Risk Management), IEC 81001-5-1 (Cybersecurity), and MDCG IVDR guidance.
• Soft Skills: Exceptional ability to translate dense technical engineering data into clear, persuasive regulatory arguments. Proven ability to thrive in a complex, matrixed environment. Must be able to influence cross-functional partners (R&D, Marketing, Quality) without direct authority, manage competing priorities across multiple project core teams, and maintain clear communication channels between functional leadership and project stakeholders.
• Leadership: Demonstrated ability to mentor junior RA staff and lead with influence across cross-functional teams.
• This position is not currently eligible for visa sponsorship.

Nice To Haves

• RAC (Regulatory Affairs Certification) is preferred.

Responsibilities

• Strategic Project Support: Serve as the RA lead on New Product Development (NPD) and Lifecycle Management (LCM) core teams. Drive regulatory strategy for hardware, software, and cybersecurity-related initiatives across Clinical Lab, Transfusion Medicine, and Point-of-Care business units.
• Submission Authoring & Technical Documentation: Author, compile, and manage high-complexity US FDA pre-market submissions (510(k), PMA, BLA, and De Novo) and EU IVDR Technical Documentation specifically for instrument platforms, embedded software, automation systems, and informatics solutions/SaMD. Participate in Pre-Submission (Q-Sub) interactions and Notified Body technical reviews to de-risk complex system architectures, interoperability considerations, and V&V strategies.
• Change Management: Conduct robust regulatory impact assessments for Design Changes, e.g., software refactoring/re-engineering, OS migrations, CAPA initiatives, environmental compliance, hardware obsolescence. Defend Letter to File / QMS justifications vs. New Submissions per FDA and international guidance.
• Digital Health & Cybersecurity: Act as the Subject Matter Expert for Section 524B compliance. Ensure Software Bill of Materials (SBOM), Threat Modeling, and Cybersecurity Management Plans meet modern "Cyber Device" requirements and post-market surveillance expectations.
• IVDR & Global Registration: EU: Lead the authoring and maintenance of IVDR Technical Documentation for complex instrument platforms and standalone software. ROW: Liaise with International RA and regional QRC teams to facilitate global market access.
• Compliance Review: Provide final regulatory sign-off for device labeling, Instructions for Use (IFU), and promotional/marketing materials to ensure alignment with cleared claims and global advertising regulations.
• Regulatory Intelligence: Monitor and interpret emerging FDA guidance (e.g., SaMD, Cybersecurity, AI/ML, pre-market and OTS software, Interoperability) and international standards (IEC 62304, IEC 81001-5-1, ISO 14971) to influence internal QMS processes and R&D roadmaps.
• Metrics & Excellence: Manage RA department KPIs and lead process improvement projects to optimize software and hardware submission workflows.
• Perform other work-related duties as assigned

Benefits

• QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level