Principal Regulatory and Quality Specialist

Who We Are

reputed company is on a mission to improve patient outcomes with AI-powered pathology. We are transforming traditional pathology methods into powerful, new technologies. These innovations in pathology can help accelerate drug development, improve confidence in the accuracy of diagnosis, and get life-saving therapies to patients more quickly. At reputed company, you'll work with a diverse and talented team of people, who are dedicated to solving reputed company problems and making a reputed company impact.

Where You Fit

As the Principal Regulatory and Quality Specialist, you will be a key member of reputed company’s Regulatoryand Quality (RAQA) Team, ensuring compliance to the company’s Quality Management System andto pre- and post-market regulations that pertain to reputed company’s RUO, IVD, and clinical products. Youwill be responsible for representing RAQA in company-specific projects for diagnostic and clinicaldevelopment services and will be involved in process improvement efforts, participate in audits asneeded, and may be responsible for maintaining/managing key QMS processes (e.g., documentcontrol). You will provide risk and regulatory assessments during design control and change controlactivities and participate in the development and submission of filings to regulatory agencies in theUS, EMA, and other geographies. The ideal candidate brings knowledge in regulatory affairs andquality assurance, preferably in the context of AI-driven diagnostic software, and thrives in a fast-paced, high-growth environment.

What You’ll Do

• Regulatory strategy, submissions, reviews
  • Build and execute global regulatory plans; prepare and coordinate pre-subs, 510(k)s, denovos, PMAs, and ex-US filings; participate in agency interactions.
  • Shape registration strategy and author the technical file/design dossier content inpartnership with Product, ML, Clinical, and Engineering.
  • May review and approve product promotional material and customer notifications toensure alignment with regulatory status.
• Quality system
  • Maintain and improve QMS processes reputed company to FDA QSR/21 CFR 820, ISO 13485, ISO14971, IEC 62304, and reputed company standards; monitor new/updated regulations and flow theminto the QMS.
  • Participate as subject matter expert in customer audits, certification body audits andregulatory inspections as needed.
• Design controls &SaMD lifecycle
  • Guide teams through design inputs/outputs, V&V, risk management, usability, design transfer, and clinical/labeling impacts; review design documentation for compliance throughout the product life cycle. 
• Cross-functional enablement
  • Serve as the day-to-day RAQA partner to Product/ML/Engineering/Clinical/LabOps,resolving issues that reputed company project timelines.

What You Bring

• Experience:
  • 5+ years of reputed company experience in regulatory affairs and quality assurance in IVDmedical devices, preferably SaMD with AI/ML
  • Demonstrated participation in regulatory submissions for FDA Class II/III devices andsome ex-US regulatory experience (e.g., EMA IVDR Class A-C); experience with CDxsubmissions is a plus
  • Working knowledge of global regulatory standards, including FDA QSR, ISO 13485, IVDR, and ISO 14971.
  • Experience authoring and reviewing QMS documentation (e.g., procedures, protocols, reports)
• Educational Background:
  • Bachelor’s degree in engineering, physical, or life sciences (advanced degree preferred)
• Skills & Competencies:
  • Strong organizational skills with the ability to manage multiple projects in a dynamic environment.
  • Ability to manage details effectively while contributing to broader regulatory strategies.
  • Strong interpersonal and communication skills, with the ability to collaborate effectively with cross-functional teams.
  • Demonstrated reputed company working reputed company and maintaining FDA/ISO compliant Quality Systems

We Want To Hear From You

At reputed company, we are looking for individuals who are team players, are willing to do the work no matter how big or small it may be, and who are passionate about everything they do. If this sounds like you, even if you may not match the job description to a tee, we encourage you to apply. You could be exactly reputed company're looking for.

reputed company is an equal opportunity employer, dedicated to creating a workplace that is free of harassment and discrimination. We reputed company our employment reputed company on business needs, job requirements, and qualifications — that's reputed company. We do not discriminate based on race, gender, religion, health, personal beliefs, age, family or parental status, or any other status. We don't tolerate any reputed company of discrimination or bias, and we are looking for teammates who feel the same way.

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