Lead and supervise a team of regulatory specialists managing labeling approvals, drug listings, and medical device submissions.
Oversee FDA compliance, quality investigations, and health hazard evaluations to ensure product integrity.
Collaborate cross-functionally with Quality Assurance, Legal, and external partners to resolve complex regulatory challenges.
The partner company is a pharmaceutical and medical device organization focused on ensuring regulatory compliance and product quality. The company fosters a collaborative and inclusive work environment, emphasizing continuous improvement and professional development.
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.
Serve as a technical lead and device subject matter resource across the medical device total product life cycle.
Analyze premarket and postmarket submissions, evaluating safety, effectiveness, and benefit-risk determinations.
Develop SOPs, real-world evidence protocols, and risk standards grounded in FDA guidance while mentoring junior engineers.
ICA, Inc. is a rapidly growing government consulting firm providing innovative solutions in public health research, advanced data science, and strategic services. Our small but collaborative team prioritizes work-life balance and supports dynamic, highly skilled professionals.
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.
Review and approve validation of software and AI products to ensure full compliance with regulatory requirements and company policies.
Prepare for and support external regulatory audits; lead internal or vendor audits related to maintaining GxP and regulatory compliance.
Develop and maintain digital/software components of quality management systems, including AI quality management systems.
Care Access brings 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, they are reimagining how clinical research and health services reach the world.
Assess manufacturers' software lifecycle processes and technical documentation for medical device software, including SaMD and AI-enabled devices, under EU MDR, UK MDR, and relevant IEC standards.
Raise and close out technical assessment findings with manufacturers, explaining regulatory requirements clearly and constructively.
Deliver consistent, high-quality assessments that match Scarlet's methodology and values, working independently with flexible scheduling.
Scarlet is a medical technology certification company that combines clinical, technical and regulatory expertise with AI agents and software to help ambitious technology companies certify AI-enabled medical devices faster without lowering safety standards. You'll join a collaborative team building the infrastructure that makes rigorous certification repeatable at scale.
Coordinate end-to-end review and approval of promotional, advertising, and commercial materials in a regulated life sciences environment.
Serve as central point of contact for internal teams and external partners, managing documentation, timelines, and approval records.
Work closely with Regulatory Affairs, Legal, Medical, Compliance, Marketing, and Commercial stakeholders to ensure efficient and compliant reviews.
A growing life sciences organization dedicated to advancing regenerative medicine through innovative products and high-quality solutions. The company fosters a collaborative culture focused on accountability, adaptability, continuous learning, and customer-centric innovation.
Support software design assurance for cloud-based, data platform, and AI/ML-enabled systems.
Lead pre-market risk management deliverables including Software Hazard Analysis and design FMEA.
Review and approve design control deliverables and support post-market activities and CAPA.
Dexcom is a pioneer and global leader in continuous glucose monitoring (CGM), creating biosensing technology to improve health outcomes. The company is driven by thousands of ambitious, passionate employees worldwide who focus on listening, integrity, and dependability.
Lead global CMC regulatory strategy for the portfolio, including Phase 3 readiness and launch planning.
Serve as the company's lead CMC voice with FDA, EMA, and other global health authorities.
Build, lead, and develop a high-performing CMC Regulatory team as the company scales.
Kailera Therapeutics is a biopharmaceutical company developing novel therapies for obesity and related conditions. The company has an entrepreneurial, team-oriented culture and is passionate about creating an inclusive workplace.
Oversee operational preparation and execution of regulatory submissions, ensuring technical compliance and timely delivery.
Manage routine submissions like INDs, CTAs, and health authority responses, while supporting complex filings and maintaining submission plans.
Compile, publish, and validate eCTD packages, coordinate submission delivery, and maintain accurate records in Veeva RIM.
A partner company of Jobgether, a pharmaceutical and biotechnology organization focused on developing innovative oncology therapies. The company values regulatory precision and operational efficiency across global programs, with a remote-first culture.