Manage daily regulatory submission operations to ensure timely, compliant, and high-quality health authority submissions.
Prepare, format, and publish complex regulatory documents according to internal standards and regulatory requirements.
Perform detailed technical quality control reviews of regulatory documents and published submission sequences.
This company specializes in regulatory operations and publishing for innovative healthcare solutions. The team operates in a fast-paced life sciences environment with a collaborative and multidisciplinary approach.
Provide regulatory advice and ensure compliance with U.S. regulations and ICH GCP guidelines for clinical research sites.
Coordinate IRB submissions, maintain regulatory documentation, and support site start-up and close-out activities.
Collaborate with cross-functional teams and monitor regulatory changes to advise stakeholders.
Care Access is working to make the future of health better for all by bringing world-class research and health services directly to communities that often face barriers to care. With hundreds of research locations, mobile clinics, and clinicians across the globe, the company is dedicated to ensuring every person has the opportunity to understand their health and contribute to medical breakthroughs.
Responsible for submission planning and management of IND-related activities, including annual reports, DSURs, and CTA activities.
Manages the compilation, QC, and submission of INDs, BLAs, and amendments, and prepares routine regulatory documents.
Represents Regulatory Affairs on cross-functional teams, providing expertise and managing submission trackers.
Iovance Biotherapeutics is a biotechnology company pioneering tumor infiltrating lymphocyte (TIL) therapy for cancer. It is a small, fast-paced company with a collaborative and innovative culture.
Coordinate and track international regulatory submissions for IVD products in the EMEA region.
Manage regulatory release of products using the GTS tool and ensure compliance with IVD/medical device regulations.
Collaborate with global teams to document regulatory assessments and oversee channel partner licenses and renewals.
Agilent provides life science, diagnostic and applied market laboratories with instruments, services, consumables, applications and expertise. With 18,000 employees worldwide, the company fosters a culture of trust, respect, integrity, and inclusivity.
Provide regulatory affairs support for FDA medical device compliance, including pre-market submissions (510(k), PMA) and facility registration.
Coordinate complaint investigations, risk assessments, and field action notifications while ensuring compliance with ISO 13485 and MDR.
Collaborate with cross-functional teams to prepare documentation, support QMS audits, and maintain regulatory records.
Fujifilm Healthcare Americas Corporation provides cutting-edge healthcare solutions including diagnostic imaging, enterprise imaging, and endoscopic/surgical imaging. With over 70,000 employees globally, the company operates in a dynamic, flexible environment that fuels creativity and collaboration.
Manage day-to-day regulatory affairs support, including clinical trial applications and compliance with global regulations.
Provide expert guidance to project stakeholders, ensuring timely and high-quality service delivery.
Develop regulatory strategies and tools, staying current with industry best practices and regulatory changes.
Alimentiv provides global regulatory affairs support services for clinical research. The company emphasizes high-quality service delivery, compliance with industry standards, and a collaborative culture.
Manage regulatory inquiries of PLICO and affiliated insurance companies.
Respond to inquiries from regulatory bodies for insurance and securities activities.
Partner with business and divisional compliance units to coordinate regulatory filings.
Protective helps protect customers against life's uncertainties. The company is a large insurance provider with a strong focus on employee well-being and a collaborative culture.
Manage regulatory activities for complex submissions across EU, GCC, and Australian markets.
Conduct regulatory research, gap analyses, and prepare submission components.
Provide regulatory expertise within multidisciplinary project teams and support business development.
The company provides regulatory consulting services for healthcare products, focusing on global markets. It fosters a collaborative, inclusive culture with opportunities for career development and meaningful impact.
Own the quality and completeness of regulatory data, ensuring customer compliance and audit readiness.
Manage recurring monitoring and verification cycles to keep regulatory coverage current and accurate.
Collaborate with Customer Success, Product, and Engineering to drive process improvements and automation.
Flinn provides regulatory intelligence for medical device manufacturers, ensuring they stay compliant with standards and regulations. It is a well-funded European startup with a high-trust, low-ego culture and a net-zero commitment.