Senior Regulatory and Quality Specialist

Job not on LinkedIn

September 15

🍂 Massachusetts – Remote

Although this job is listed in Massachusetts, this company may be open to hiring remote in other states.

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

Apply Now

Receive Emails with Similar Jobs

PathAI

WebsiteLinkedInAll Job Openings

Artificial Intelligence • Healthcare Insurance • Biotechnology

PathAI is a leading healthcare technology company dedicated to advancing pathology through the use of artificial intelligence. Their mission is to improve patient outcomes by providing AI-powered technology that offers valuable insights for biomarker discovery and drug development. PathAI collaborates closely with biopharma and pathology laboratories to enhance laboratory workflows and improve diagnostics. Their AI-driven pathology solutions, such as the AISight Digital Pathology Image Management System, are utilized by major laboratories and research centers worldwide, helping to power digital pathology and precision medicine initiatives. PathAI's technology is leveraged by top biopharma companies to transform drug discovery and diagnostics, making significant contributions to the fields of healthcare and biotechnology.

501 - 1000 employees

Founded 2016

🤖 Artificial Intelligence

⚕️ Healthcare Insurance

🧬 Biotechnology

💰 $165M Series C on 2021-05

📋 Description

• Ensure compliance to the company’s Quality Management System and to pre- and post-market regulations that pertain to PathAI’s RUO, IVD, and clinical products • Represent RAQA in company-specific projects for diagnostic and clinical development services • Maintain/manage key QMS processes (e.g., document control) and improve QMS aligned to FDA QSR/21 CFR 820, ISO 13485, ISO 14971, IEC 62304 • Provide risk and regulatory assessments during design control and change control activities • Participate as subject matter expert in customer audits, certification body audits and regulatory inspections as needed • Build and execute global regulatory plans; prepare and coordinate pre-subs, 510(k)s, de novos, PMAs, and ex-US filings; participate in agency interactions • Shape registration strategy and author technical file/design dossier content in partnership with Product, ML, Clinical, and Engineering • Review and potentially approve product promotional material and customer notifications to ensure alignment with regulatory status • Guide teams through design inputs/outputs, V&V, risk management, usability, design transfer, and clinical/labeling impacts • Serve as the day-to-day RAQA partner to Product/ML/Engineering/Clinical/LabOps, resolving issues that affect project timelines

🎯 Requirements

• 5+ years of progressive experience in regulatory affairs and quality assurance in IVD medical devices, preferably SaMD with AI/ML • Demonstrated participation in regulatory submissions for FDA Class II/III devices and some ex-US regulatory experience (e.g., EMA IVDR Class A-C); experience with CDx submissions is a plus • Working knowledge of global regulatory standards, including FDA QSR/21 CFR 820, ISO 13485, IVDR, and ISO 14971 • Experience authoring and reviewing QMS documentation (e.g., procedures, protocols, reports) • Bachelor’s degree in engineering, physical, or life sciences (advanced degree preferred) • 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 success working within and maintaining FDA/ISO compliant Quality Systems

🏖️ Benefits

• Remote work option (#LI-Remote) • Work with a diverse and talented team • Mission-driven work improving patient outcomes with AI-powered pathology