- Lead the development, implementation, and continuous improvement of eMyosound's Quality Management System (QMS) encompassing design, development, manufacturing, and distribution.
- Collaborate with cross-functional teams to develop and maintain accurate, compliant QMS documentation.
- Drive the company towards achieving and maintaining ISO 13485 certification for the QMS.
- Serve as a trusted advisor to R&D and clinical teams on regulatory and quality matters, ensuring seamless integration of requirements into product development and clinical studies.
- Contribute to successful premarket regulatory submissions in the US and EU, ensuring timely market access.
- Bachelor's or Master's degree in Engineering, Life Sciences, or a related field.
- 2+ years of proven experience in quality assurance and regulatory affairs roles within the medical device industry.
- Demonstrated expertise in US and EU (MDR) regulations, including experience with relevant submissions (e.g., 510(k), PMA, Technical Files).
- Working knowledge of Good Clinical Practices (GCP) and their application in medical device development.
- Experience with active medical device design and manufacturing processes (hardware and software).
- Excellent problem-solving, analytical, and critical thinking skills.
- Proven track record of critically evaluating current practices, questioning assumptions, and proposing alternative approaches to achieve better results.
- Strong communication and interpersonal skills, with fluency in English (written and spoken).
- Ability to work both independently and collaboratively within a fast-paced environment.
- A proactive and results-oriented mindset, with a passion for continuous improvement.
- Join an international team celebrated for its pioneering spirit and cutting-edge advancements.
- Collaborate with renowned academic and medical institutions.
- Contribute to a bold vision with a roadmap brimming with exciting and impactful projects.
- Become an integral part of a team of exceptional talent, working together to transform healthcare.
- Thrive in a supportive environment that prioritizes work-life balance, offering flexible remote work options and a range of attractive benefits.
Quality and regulatory affairs engineer - Tours, France - eMyosound
Description
eMyosound develops an innovative medical device to diagnose heart failure using ultrasound.
Join eMyosound as a Quality Assurance & Regulatory Affairs (QARA) Engineer and be part of a collaborative team dedicated to medical device excellence. You'll have the opportunity to develop your skills in QMS implementation under the mentorship of the QARA Director, while working closely with R&D to ensure product conformity and regulatory compliance.
Responsibilities
Profile
We are seeking a driven and detail-oriented QARA Engineer to join our team. You will play a pivotal role in ensuring our medical devices meet the highest quality standards and comply with global regulations. This is a hands-on position where your expertise in both quality control and regulatory affairs will directly impact patient safety and product success.
Why join us
Embark on a groundbreaking journey with an innovative Healthtech startup:
About the position
We're offering a permanent, full-time position in our Tours office, conveniently located near the train station. While you'll have the opportunity for remote work, we require a minimum of two days per week in the office to foster collaboration and team connection.