Lead QMS and regulatory remediation to align global procedures with FDA QMSR and ISO 13485.
Manage global regulatory submissions and interactions with Notified Bodies for EU MDR, UKCA, and other markets.
Serve as RA representative on core project teams for hardware and AI/software releases.
Eko Health develops AI-powered digital stethoscopes and ECG tools to help clinicians detect heart and lung disease. The company is venture-backed, recognized by TIME as a top healthtech company, and has a mission-driven team of engineers, physicians, and creatives.
Secure regulatory approvals for innovative medical devices in the Indian market.
Collaborate with global regulatory teams on submissions, documentation, and compliance.
Interpret local regulations and support BIS certification and import/export requirements.
The company develops innovative medical devices and operates in a global healthcare technology environment. It values regulatory compliance, cross-functional collaboration, and professional growth, with a remote-friendly and internationally connected culture.
Develops and drives regulatory strategy for FDA Pharma and IVDR initiatives.
Represents the regulatory function on cross-functional teams and interacts with regulatory authorities.
Coordinates regulatory submissions and ensures compliance with global requirements.
Natera is a clinical genetic testing company specializing in non-invasive cell-free DNA and liquid biopsy testing. The team consists of highly dedicated professionals from world-class institutions who care deeply for their work and each other.
Provide scientific, strategic, and commercial leadership for Product Safety Labs' medical device biocompatibility business.
Collaborate with Study Directors, laboratory management, and business development to strengthen scientific capabilities and expand service offerings.
Represent PSL through client engagement, scientific presentations, publications, and standards committees.
Eurofins Scientific is an international life sciences company providing analytical testing services to make life and our environment safer, healthier and more sustainable. With over 58,000 staff across 900 laboratories in more than 54 countries, Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing.
Support Clinical Trial Managers with study start-up, protocol development, and Trial Master File preparation.
Coordinate with clinical sites on documentation, training, and compliance with FDA and GCP requirements.
Assist with tracking study payments and providing operational support across the full study lifecycle.
The company is a partner organization specializing in clinical research and development, operating through Jobgether. It offers a structured clinical operations environment with cross-functional teams and professional growth opportunities.
Develop and maintain integrated project plans for global regulatory submissions, ensuring adherence to scope, timelines, budgets, and quality standards.
Act as the primary regulatory timeline contact across Clinical, Nonclinical, CMC, Quality, and Commercial functions, fostering collaboration and alignment.
Identify and mitigate project risks, prepare teams for agency meetings, and lead responses to regulatory queries from global health authorities.
Centessa Pharmaceuticals is a clinical-stage company developing orexin receptor 2 agonists for narcolepsy and other sleep-wake disorders. As a wholly owned subsidiary of Eli Lilly and Company, it shares a culture of caring and impact with over 50,000 employees.
Lead U.S. and global regulatory strategies for oncology biologic development programs.
Prepare and manage Clinical Trial Applications, Marketing Applications, and regulatory amendments.
Collaborate with cross-functional teams to align regulatory plans and manage program risks.
A partner company is seeking a strategic regulatory affairs leader to support innovative oncology biologic and cell/gene therapy development programs. The company offers a fully remote environment with global regulatory exposure and cross-functional collaboration.