The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
European Union Regulatory Affairs, Medical Device, Quality/Risk Management, US Regulatory Affairs
4 Year Degree
The Regulatory Affairs Specialist provides regulatory support for new product development submissions and post market support for existing products, including creation of regulatory deliverables and managing international regulatory registrations. This person works with the Director of Quality, Regulatory & Cybersecurity to develop global regulatory strategies and impact assessments.
• Three years working in medical device or other regulated industry.
• Experience creating and submitting pre-market submissions for medical devices.
• Experience with medical device quality management systems (FDA QSR, ISO-13485).
• Knowledge of international medical device regulations including EU MDD/MDR.
• Ability to travel - National/International – up to 10%
• Ability to create collaborative, cross-functional partnerships.
• Effective presentation and communication skills.
• Ability to solve problems and make sound decisions
Internal Number: 0001
About CapsuleTech, Inc.
Capsule Technologies is a leading global provider of medical device integration, clinical surveillance and patient monitoring for hospitals and healthcare organizations. Our platform captures streaming data from virtually any medical device and transforms that data into context rich information to clinical documentation, alarm management, patient surveillance, decision support and research. Our end-to-end data management and connectivity supports better collaboration and communication, improves patient safety and overall satisfaction.