Strategize, plan, and author regulatory plans and activities to optimally position GRAIL products with the FDA and/or global health authorities.
Support the U.S. Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval reports, annual reports, export certificates, establishment registrations, and device listings.
Serve as a key member of the Regulatory team, offering insights and solutions on corporate product portfolios and strategies.
Provides regulatory guidance throughout the clinical development life cycle.
Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards.
Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers
Precision for Medicine integrates clinical trial execution with scientific knowledge, laboratory expertise, and data sciences, focusing on Oncology and Rare Disease. The company values employee contributions and nurtures ideas, striving for positive change.
Lead global regulatory activities for cell therapy programs as the Global Regulatory Lead. Shape regulatory strategy, lead health authority interactions, and support documentation. Collaborate with Clinical, CMC, Nonclinical, Quality, and Program Management teams.
BlueRock Therapeutics LP is a clinical stage cell therapy harnessing the power of cell therapy to create a pipeline of new medicines for people suffering from neurological and ophthalmic diseases.
Engage, educate, and support Galleri ordering providers and cancer diagnostic specialists, oncologists, Key Opinion Leaders (KOLs), and Health Care System (HCS) influencers.
Maintain in-depth clinical, scientific, and technical expertise related to GRAIL’s products, cancer screening, and cancer diagnostic guidelines.
Summarize and communicate complex medical messages to enable clear and concise understanding by both external audiences and partners within GRAIL.
GRAIL is a healthcare company, pioneering new technologies to advance early cancer detection. They have built a multi-disciplinary organization of scientists, engineers, and physicians and are supported by leading global investors and pharmaceutical, technology, and healthcare companies.
Support software validation and verification efforts to ensure compliance with FDA regulations and industry standards.
Own the quality approval process for software components, including documentation review and final release approvals.
Partner with the software engineering team to implement and maintain a robust software quality management system.
Sequel, headquartered in Manchester, New Hampshire, is developing the next generation of transformative drug-delivery advancements starting with diabetes. Sequel’s approach is to look at diabetes management holistically to advance systems that make living with diabetes simpler and easier for all. Sequel provides equal employment opportunities and believes that when you thrive, they thrive.
Responsible for leading the strategic direction, management, and oversight of the organization’s regulatory compliance program.
Manage a team of compliance professionals, ensuring that the company operates in full adherence to applicable laws, regulations, and industry standards.
Drive the development and implementation of enterprise-wide compliance frameworks, oversee risk assessments, support regulatory interactions, and champion a culture of compliance across the organization.
Truelogic is a leading provider of nearshore staff augmentation services headquartered in New York. Their team of 600+ highly skilled tech professionals, based in Latin America, drives digital disruption by partnering with U.S. companies on their most impactful projects.