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.
Own regulatory review and approval of promotional materials across HCP, DTC, digital, and social channels, ensuring compliance with FDA regulations.
Partner with Commercial, Medical Affairs, and Legal to shape campaigns and claims, providing clear guidance to reduce approval delays.
Lead FDA promotional submissions, monitor regulatory trends, and build scalable processes to support product launches.
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders. The company values Trust, Ownership, Curiosity, and Results, and offers a collaborative, high-achieving environment with a focus on diversity and inclusion.
Lead analytical strategies for commercial products, ensuring compliant and robust methods and specifications.
Manage method transfers, validations, and lifecycle activities while collaborating with CDMOs and cross-functional teams.
Contribute analytical expertise to regulatory submissions and support health authority inspections.
The company is a science-driven biopharmaceutical organization focused on developing and commercializing small-molecule drugs. They foster a collaborative culture with engaged colleagues and emphasize scientific excellence.
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.
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.
Oversee content compliance review for marketing, educational, and communications materials, ensuring alignment with pharmacy regulations and FDA/FTC guidelines.
Collaborate cross-functionally with Compliance, Clinical, Marketing, and Legal teams to provide risk-based guidance and streamline content approval workflows.
Develop training resources, manage review queues in Asana, and maintain auditable documentation to support compliance and process improvement.
Strive Pharmacy is a personalized compounding pharmacy focused on individualized care, creating medications tailored to each patient's needs. The company is growing and fosters a culture of community and professional development, with team events and a commitment to employee growth.