Provide regulatory affairs support for FDA medical device compliance, including pre-market submissions (510(k), PMA), post-market surveillance, and quality system audits.
Collaborate cross-functionally with R&D, Quality Assurance, and Sales to ensure compliance with U.S. FDA and international regulations (ISO 13485, MDSAP, EU MDR).
Perform regulatory documentation and submissions for new products and changes, and handle customer complaints, field actions, and risk assessments.
FUJIFILM Healthcare Americas Corporation provides cutting-edge healthcare solutions spanning diagnostic imaging, enterprise imaging, endoscopic and surgical imaging, and in-vitro diagnostics. The company is part of Fujifilm, which has over 70,000 employees globally and fosters a dynamic, flexible environment focused on innovation and collaboration.
Review CMC sections of regulatory submissions for drug-device combination products, ensuring accuracy and alignment with global requirements.
Contribute to global regulatory CMC strategies and provide guidance to cross-functional stakeholders.
Collaborate with device development, quality, clinical, human factors, and other teams to support product compliance and change controls.
The company specializes in drug-device combination products and operates in a cross-functional, science-driven environment. The culture emphasizes collaboration across regulatory, device development, quality, clinical, and human factors teams.
Provides regulatory CMC support for drug-device combination products.
Reviews submission documentation and contributes to global regulatory strategies.
Collaborates with cross-functional teams including device development, quality, and clinical.
Vertex Pharmaceuticals is a global biotechnology company dedicated to developing transformative medicines for serious diseases. With thousands of employees, it fosters a collaborative and innovative culture focused on patient impact.
Oversee CRO and vendor activities while directly contributing to study start-up and conduct including site initiation and monitoring visits.
Verify accuracy and completeness of clinical data, source documentation, and regulatory files ensuring compliance with GCP, GDPR, and regulations.
Identify and resolve discrepancies in study documentation and maintain Trial Master File for audit readiness.
Anteris Technologies is a global structural heart company dedicated to revolutionizing cardiac care through biomimetic TAVR valves. The company has a growing and inclusive team with offices in the US, Switzerland, and Australia.
Serve as Global Process Owner for CAPA subsystem, ensuring compliance with FDA, ISO, and EU MDR requirements.
Lead complex investigations using root cause analysis tools and mentor cross-functional teams on best practices.
Monitor CAPA performance through KPIs, facilitate CAPA Review Board, and drive systemic improvements.
Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease using AI-driven, non-invasive cardiac tests. The company is publicly traded, has been used for over 500,000 patients worldwide, and is supported by international medical societies.
Conduct technical and clinical assessments of non-active orthopaedic devices under EU MDR 2017/745 and UK MDR 2002.
Support CE and UKCA marking, ensuring compliance and minimizing regulatory risks for device certification.
Communicate with stakeholders, train junior staff, and manage schedules to deliver timely assessments.
SGS is a world-leading testing, inspection and certification company focused on quality and integrity. Our 99,600 employees in 2,600 offices enjoy a dynamic, international culture with strong development opportunities.
Develop Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs) per EU MDR to support CE Mark submissions.
Interact with cross-functional teams to define strategies for clinical documentation and regulatory submissions.
Conduct literature searches, critically appraise scientific data, and write clinical summaries for products and surgical procedures.
Intuitive is a global leader in robotic-assisted surgery and minimally invasive care, developing technologies like the da Vinci surgical system and Ion to transform surgery. The company is a team of engineers, clinicians, and innovators united by a purpose to make surgery smarter, safer, and more human, with challenging but deeply meaningful work.
Lead global regulatory strategy for assigned programs, overseeing processes and managing risks to achieve successful registration and lifecycle management.
Collaborate cross-functionally with teams including toxicology, pharmacology, and clinical development to support clinical programs and regulatory submissions.
Serve as point of contact with health authorities, interpret regulatory guidelines, and drive innovative approaches to regulatory sciences.
Recursion is a clinical-stage TechBio company that uses AI and technology to decode biology and accelerate drug discovery and development. The company employs hundreds across multiple global offices and values integrity, collaboration, and bold action.