Own Cadence's QMS strategy and regulatory operating model for AI-enabled healthcare software, SaMD, and technology-enabled care workflows.
Lead quality system governance across design controls, risk management, CAPA, change control, document control, training, and audit readiness.
Partner with Product, Engineering, and Clinical teams to assess regulatory pathway, device classification, and QMS requirements for new software capabilities.
Cadence is a clinical AI company that delivers continuous, proactive care for older adults with chronic conditions. They operate as a full clinical care delivery organization with clinicians working alongside health system partners, helping Medicare save $2M a week.
Leads global regulatory strategy and compliance for Merge Healthcare’s medical imaging portfolio.
Oversees global product registrations, device licensing, and market authorization activities.
Provides leadership and expert guidance on emerging regulations and standards.
Merative provides data, analytics, and software for health and social care. It is a medium-to-large company with a remote-first culture and values focus, speed, trust, and inspire.
Support regulatory and quality processes to ensure compliance with applicable requirements, focusing on product design, development, and manufacture of medical devices.
Assist in drafting regulatory submissions for domestic and worldwide commercialization and provide guidance on product labeling and lifecycle planning.
Evaluate regulatory impact of changes, manage product recall activities, and participate in internal and third-party quality audits.
Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. The company is dedicated to developing better solutions for life from discovery to diagnosis and fosters an innovative culture for talented individuals to solve tough problems.
Lead batch release activities and provide GMP oversight for manufacturing partners to ensure compliance with global regulations.
Manage investigations, deviations, CAPA, and change controls while supporting audits and inspections.
Mentor and develop junior QA staff and contribute to quality system improvements.
Deciphera is a biopharmaceutical company dedicated to developing innovative therapies for cancer. The company fosters a collaborative culture with opportunities for personal and professional growth.
Define and execute global regulatory strategies across early- and late-stage development for small molecules and combination products.
Lead and oversee interactions with FDA, EMA, and other global regulatory agencies.
Author, review, and submit key regulatory documents, including INDs, CTAs, briefing books, and response packages.
Enveda reinvents drug discovery by harnessing nature's intelligence, identifying new medicines four times faster than the industry standard. The company achieved unicorn status after a $150M Series D in 2025, has an award-winning culture recognized by Newsweek and Forbes, and values creativity, collaboration, and deep respect for each team member.
Execute regulatory strategies for obtaining registration approval of Intuitive's medical device portfolio in APAC indirect markets.
Coordinate with Distributor RAs and internal stakeholders to compile regulatory documentation and ensure compliance with medical device regulations.
Manage regulatory submission tracking in systems like Veeva and perform periodic surveillance activities using TrackWise.
Intuitive is a pioneer and market leader in robotic-assisted surgery, dedicated to advancing minimally invasive care. The company has built an inclusive and diverse team of great people for over 25 years, grounded in integrity and a strong capacity to learn.
Act as subject matter expert for the Document Control process area, owning lifecycle management of quality processes and records.
Serve as System Administrator of Veeva’s internal electronic Document Management System (eDMS), responsible for configuration and continuous improvement.
Provide quality oversight on regulated activities, such as process definition, validation testing, and product releases for in-scope systems.
Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $3B in revenue in our last fiscal year with extensive growth potential ahead.
Own the end-to-end quality function within Operations, including supplier qualification, NPI, and RMA processes.
Lead supplier quality management, audits, and improvement programs for critical components.
Drive product certifications (CE, FCC, UL) and maintain the quality management system aligned with ISO 9001.
Axelera AI is a deep-tech startup creating the next-generation AI platform to advance humanity. With over 220 employees and $370 million raised, they have a world-class team including 49+ PhDs and offices across Europe.