Source Job

• 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.

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 using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges.

The Senior Director, Product Security will define and lead the product security strategy for the medical device portfolio. Key responsibilities include developing and executing a comprehensive product security strategy aligned with business and regulatory objectives. This role requires overseeing end-to-end product security management, ensuring compliance with regulations and standards.

iRhythm is a leading digital healthcare company that creates trusted solutions that detect, predict, and prevent disease.

• 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.

• Ensure the quality and regulatory compliance of AI-powered SaMD products.
• Collaborate with cross-functional teams, including software development, regulatory affairs, and quality assurance.
• Maintain and review audit-ready evidence for software/AI development.

Sword Health is an AI health company that provides care programs for multiple conditions, from musculoskeletal, to women’s health, to mental health.

The Manager, Quality Assurance & Regulatory will support global quality systems, product integrity, and regulatory compliance. Heavily focused on quality assurance, including product testing, technical packaging, supplier quality management, and continuous improvement initiatives. Partner closely with Product Development, Operations, Packaging, Creative, and Customer Experience to ensure products meet Starface’s high standards.

Starface World is reinventing the way we care for acne-prone skin as the first complexion brand to combine efficacy and optimism.

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.

Oversee regulatory operations across our expanding national footprint. Guide state higher education approvals, partner with campus and executive leaders. Shape the regulatory framework that supports our mission to transform nursing education.

Arizona College of Nursing transforms people’s lives by preparing them for careers in nursing and improving communities through the care its graduates provide.

• 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.

• Define and execute market research strategies to inform platform direction.
• Build and maintain platform product roadmaps aligned to Clario’s strategic priorities.
• Manage the full product lifecycle from ideation through retirement, ensuring alignment with quality, regulatory, and data governance standards.

Clario is a leading provider of endpoint data solutions to the clinical trials industry, generating high-quality clinical evidence for life sciences companies.

The Upstream Senior Clinical Program Manager will design and execute pre-market feasibility and pivotal clinical studies, ensuring regulatory compliance while supporting marketing claims. This role requires close collaboration with physician collaborators and internal stakeholders to collect, analyze, and interpret clinical data. The role offers remote flexibility, with occasional travel for on-site meetings and conferences.

This position is posted by Jobgether on behalf of a partner company.

• Lead global pharmacovigilance operations and ensure the safety of clinical and post-marketing products.
• Collaborate with cross-functional teams to maintain compliance with global regulatory standards.
• Drive continuous improvement of PV systems and processes while contributing to medical safety strategy.

This position is posted by Jobgether on behalf of a partner company; Jobgether uses an AI-powered matching process to ensure your application is reviewed quickly.

• Develop, manage, and execute global clinical studies.
• Ensure timely and budget-compliant trial activities in accordance with quality standards.
• Lead the selection and oversight of clinical trial sites.

This position is posted by Jobgether on behalf of a partner company.

• 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.