Medical Device Regulatory

We have a dental device that has just been issued initial our USPTO patent; Further USPTO applications as well as PCT filings are in process. We are accelerating our Go to Market in the US, and are also close to launch in EU (FRA, ESP, GER). Our company is based in France with a ...

We are looking for ISO expert especially around Cables and Flame test for them to help us with US FDA Filing. · ...

We are developing a sophisticated medical device that integrates Mechanical Design, Electrical Hardware, Firmware and AI Models. We are looking for a Quality/Regulatory specialist to audit our current project structure on OneDrive and reorganize it into a compliant Design History ...

The Contract Regulatory Affairs Specialist – Class IV Medical Devices will play a critical role in supporting the preparation and management of Class III and IV Medical Device License (MDL) submissions to Health Canada. · ...

Experienced FDA regulatory consultant needed to provide guidance on low-level laser therapy device for hair regrowth. Must have proven experience with FDA medical device submissions and excellent communication skills. · ...

I'm looking for guidance on US FDA regulatory considerations for selling portable home-use hyperbaric oxygen chambers (mild pressure ~1.3–1.5 ATA) · ...

We are developing an FDA Regulatory Co-Pilot for medical device classification and regulatory pathway support (510(k), De Novo). We are looking for an experienced FDA regulatory specialist to perform a short structured test of the system. · Spend approximately 1–2 hours testing t ...

Nous croyons que le bonheur au travail repose sur un bon jumelage entre le rôle, · l'entreprise et l'environnement. L'environnement de travail est international. · Collaboration agilité innovation guident les décisions stratégiques. ...

We're a mission and values driven company with tremendous dedication to our customers. Our 100% remote team, spread across the US and Canada, is dedicated to a common goal – to revolutionize healthcare through innovation, collaboration, · Bachelor's degree in a related field or a ...

+The Quality Assurance & Regulatory Affairs Associate is responsible for maintaining and executing quality documentation and compliance activities aligned with ISO 13485, FDA 21 CFR Part 820, MDSAP, as well as ICH-GCP and clinical research quality requirements.Maintain and update ...

I'm building a device that provides drug free menstrual pain relief and I want build a physical prototype for Regulatory approval and live pitch deck presentation before approaching potential investors. · ...

Se busca un Regulatory Affairs Manager para liderar las actividades regulatorias y asegurar la aprobación y mantenimiento oportunos de los portafolios farmacéuticos, biológicos, dispositivos médicos y productos naturales. · ...

The Regulatory & Quality Assurance Associate is responsible for the support of all Regulatory affairs and Quality assurance activities. · DIMENSIONS OF THE POSITION · The successful candidate should ideally have a Bachelor of Science degree along with Quality assurance/Regulatory ...

We are seeking a detail-oriented and motivated individual to join our team as a Quality Assurance and Regulatory Affairs Specialist for full-time employment. · In this role, you will play a crucial part in ensuring that our products and services adhere to regulatory requirements ...

· We are seeking a detail-oriented and motivated individual to join our team as a Quality Assurance and Regulatory Affairs Specialist for full-time employment. · This role is based out of the South Vancouver office. · In this role, you will play a crucial part in ensuring that o ...

Experienced quality and regulatory professional to own, maintain, and continuously improve our ISO 13485 Quality Management System while supporting regulatory activities for existing and new medical device products. · ...

Job summary · Drive Diagnostic Innovation – Join Us as a Regulatory Affairs Associate · Competitive Salary & 100% Employer-Paid Benefits · ...

We are developing a low-cost, minimally invasive surgical robotic system designed for emerging markets. Our focus is on building a functional alternative to current high-cost platforms, with emphasis on affordability, safety, and accessibility. · ...

L'ingénieur(e) R&D – Câbles II joue un rôle clé dans la définition, la conception et les essais de systèmes de câbles et de harnais pour des dispositifs médicaux d'ablation en électrophysiologie (EP). · ...

We are seeking a highly motivated and detail oriented individual with experience working in Quality Assurance and Regulatory Affairs to ensure that our products and services adhere to regulatory requirements and meet the highest quality standards. · Conduct document control activ ...