Ensure product quality by thoroughly testing new versions of AutoContour prior to release
Execute verification and validation (V&V) testing to maintain product integrity and performance
Partner with Success and Support teams to troubleshoot issues and support clinic implementations
Radformation transforms the way cancer clinics deliver care with innovative software that automates and standardizes radiation oncology workflows. They are a fully remote, mission-driven team united by a shared goal: to reduce cancer’s global impact.
Preparation and submission of regulatory dossiers.
Advise on strategies and registration requirements for product development and marketed products.
Lead regulatory assessment and actions for changes to product and QMS processes.
Convatec is a global medical products and technologies company focused on solutions for the management of chronic conditions. They have more than 10,000 colleagues and provide products and services in around 90 countries, promising to be forever caring.
Act as the Person Responsible for Regulatory Compliance (PRRC) under EU Medical Device Regulation (MDR).
Partner closely with Product, Engineering, Machine Learning and Data, Customer Care and Legal teams.
Help build and strengthen Docplanner's regulatory framework, directly supporting EU MDR compliance and global expansion.
Docplanner Group's mission is to help people live longer, healthier lives. As the world’s largest healthcare platform, they connect 24 million patients with 280k doctors across 13 countries. Docplanner's marketplaces, SaaS and AI tools simplify daily tasks and help doctors, clinics and hospitals work more efficiently.
Partner with Regulatory Affairs and Quality Assurance teams to create software validation processes.
Coordinate software testing efforts within and across teams.
Support recruitment, technical staffing, and organizational design to grow the testing team.
Freenome is a company focused on early cancer detection through innovative diagnostic products that leverage their engineering software platform. They are a high-profile tech organization experiencing rapid growth, valuing diversity, and committed to equal opportunity.
Manage the end-to-end process for complaints and deviations.
Analyze quality metrics and suggest process optimization.
Jobgether uses an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. The final decision and next steps (interviews, assessments) are managed by their internal team.
Designing and executing comprehensive test strategies across the TALON engineering portfolio.
Leading test planning, test case development, defect tracking, and verification and validation activities.
Working closely with software developers, systems engineers, and the O&M contractor to identify and resolve defects.
DMI is a leading provider of digital services and technology solutions. They focus on end-to-end managed IT services and are committed to delivering secure, efficient, and cost-effective solutions, recognized as a Top Workplace.
Knowledge of computer based medical systems, networking protocols, and information security as it applies to medical technology.
Competency in conducting a medical equipment management program compliant with healthcare standards and regulatory agencies.
Ability to manage a recall and safety alert program for medical devices, including hazard investigations, to assure compliance.
Ibility is a Service-Disabled Veteran-Owned Small Business and a Woman-Owned Small Business. They help government leaders to achieve their mission by designing creative products and programs. Their team is fun, passionate, bold, and creative.
Serve as the enterprise Inspection Readiness Leader by defining strategy, policies, standards, governance frameworks, roles, responsibilities, escalation pathways, and operating models across all ARI sites and functions.
Design, implement, and sustain a standardized enterprise inspection readiness program, including lifecycle models for pre-inspection, active inspection, and post-inspection phases.
Provide enterprise-level oversight of inspection readiness posture, assess site readiness maturity using risk-based criteria and inspection indicators, and identify systemic inspection risks requiring enterprise remediation.
American Regent, Inc., a Daiichi Sankyo Group Company, is a top-10 injectable manufacturer, developing, manufacturing, and supplying high-quality generic and branded injectables. They have locations in New York, Ohio, and California and sales territories nationwide and have been in business for over 50 years.
Lead and manage technical functions for all medical schemes, globally.
Ensure compliance with ISO 13485, MDSAP, UKCA, and EU MDR / EU IVDR requirements.
Drive continuous improvement of technical workflows and quality management processes.
SGS is the world's leading testing, inspection, and certification company, recognized as the global benchmark for sustainability, quality, and integrity. With 99,600 employees across 2,600 offices and laboratories, we enable a better, safer, and more interconnected world.
Liaise with regulatory authorities on technical/regulatory questions.
Provide technical expertise to the global Medical Devices network.
Manage the team of IVDR product assessors and IVDR IHC.
SGS stands as the world's foremost testing, inspection, and certification company, recognized globally for sustainability, quality, and integrity. With 99,600 employees across 2,600 offices and laboratories, we foster a dynamic, international culture committed to high professional standards and long-term employee development.
Investigate product complaints and evaluate potential adverse events.
Analyze field complaints and support product investigations.
Ensure complaint handling complies with FDA and ISO regulations.
Fusion Life Sciences Technologies is a WBE-certified Healthcare Staffing and Engineering Services provider supporting industries including Pharma, Medical Devices, Aeronautical, Supply Chain, Heavy/Light Industrial, Food & Beverage, and Automotive. Their wide network of consultants and contract-to-hire engineers brings deep expertise across various sectors, leveraging AI-powered software for sourcing and screening top talent with rapid response times.
Assists in the maintenance of structures and processes which support improvement and patient safety.
Uses clinical knowledge in formal and informal consultation with individual staff, clinicians and managers, to address clinical quality and safety concerns.
Participates in clinical adverse event task groups.
Dartmouth Health is a nationally recognized Academic Medical Center set in the White Mountains of New Hampshire, stretching over New Hampshire and Vermont. They offer a rigorous, research-focused environment and are anchored by the academic Dartmouth Hitchcock Medical Center in Lebanon, NH.
Assume leadership and functional representation for projects ensuring effective coordination and management of regulatory deliverables.
Perform quality control of regulatory intelligence screening and ensure maintenance of the regulatory intelligence database.
Provide regulatory strategic input to internal and external customers and promptly identify and address any risk.
PrimeVigilance, part of Ergomed Group, is a specialized mid-size pharmacovigilance service provider established in 2008. They have achieved global organic growth year after year, with staff based across Europe, North America, and Asia, covering services within Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.
Own the end-to-end product roadmap for CDS capabilities from discovery through launch and iteration
Lead requirements gathering with clinical stakeholders including physicians, nurses, and pharmacists
Translate clinical and technical requirements into actionable user stories and acceptance criteria
Oddball believes that the best products are built when companies understand and value the things they are working on. They value learning and growth and the ability to make a big impact at a small company.
Develop and maintain data quality monitoring frameworks, including defining key data quality metrics and thresholds
Build and maintain quality dashboards and reports using programming languages (e.g., SQL, Python) and BI tools to provide near real-time study insights
Ensure compliance with ICH-GCP, 21 CFR Part 11, HIPAA, and applicable FDA expectations for regulated SaMD trials
Oura's mission is to empower every person to own their inner potential. Their award-winning products help their global community gain a deeper knowledge of their readiness, activity, and sleep quality by using their Oura Ring and its connected app. As a quickly growing company focused on helping people live healthier and happier lives, they ensure that their team members have what they need to do their best work — both in and out of the office.
Provide intraoperative and non-intraoperative technical phone support to customers and field personnel.
Analyze and troubleshoot complex robotic problems using remote diagnostics over the telephone.
Drive resolution of all product performance issues until an acceptable solution is identified.
Intuitive is a global leader in robotic-assisted surgery and minimally invasive care. They have transformed how care is delivered for millions of patients worldwide and are a team of engineers, clinicians, and innovators united by one purpose.
Design, develop and implement core application features.
Provide guidance to team members to resolve complex technical challenges.
Analyze requirements and propose high-level design and technical solutions.
Smile Digital Health provides a FHIR-based data liberation platform, enabling healthcare stakeholders to collect and exchange data. They strive towards better global health and have an innovative health data platform used in over 20 countries.
Own the execution of clinician chart audits and watchlist tracking.
Investigate clinical incidents, chart audits, and collaborate on root cause documentation.
Track quality, safety, and clinician performance metrics using manual and automated tools.
Wheel is evolving the traditional care ecosystem by equipping the nation's most innovative companies with a premier platform to deliver high-quality virtual care at scale. They offer proven strategies and cutting-edge technologies to foster consumer engagement, build brand loyalty, and maximize return on investment.
Under the direction of a senior member of the team, assume leadership and functional representation for projects of low complexity assigned ensuring effective and rapid coordination and management of deliverables striving the team to meet the agreed targets and to comply with the agreed procedures, trackers and templates.
Perform quality control of regulatory intelligence screening of legislative requirements updates and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes.
Provide internal teams and Clients with expertise and guidance on national requirements.
Ergomed Group is a rapidly expanding global full-service mid-sized CRO specializing in Oncology and Rare Disease. The company includes the more specialised brands- PrimeVigilance, Adamas Consulting and Ergomed CRO and values employee experience, well-being and mental health.
Perform timely preventative maintenance of medical equipment.
Troubleshoot, service repairs and installations.
Maintain customer relationships and ensure timely communication.
GE HealthCare partners with customers, providing medical technology, devices, and care solutions. They strive for a world where healthcare has no limits and offer a collaborative and supportive culture.