Regulatory Affairs Engineer
vor 16 Stunden
AVVie is an exciting early stage medical device company with an innovative, minimally invasive technology for the treatment of mitral valve disease.
If you are interested in joining a young and international start-up active in medical technology in Vienna.
TasksPrimary responsibility is to prepare and manage regulatory submissions, ensure compliance with MDR, FDA, and ISO standards, and provide strategic guidance throughout the product lifecycle to achieve global market approval.
- Prepare, review, and maintain technical documentation for regulatory submissions (e.g., CE Mark, FDA 510(k), PMA).
- Ensure compliance with MDR, FDA 21 CFR Part 820, ISO 13485, and other relevant standards.
- Collaborate with R&D, Quality, and Clinical teams to align product development with regulatory requirements.
- Act as the primary contact for regulatory agencies, notified bodies, and external partners.
- Monitor changes in regulatory frameworks and update internal processes accordingly.
- Conduct regulatory risk assessments and support the development of mitigation strategies.
- Participate in internal and external audits, providing regulatory support and ensuring adherence to standards.
- Drive regulatory timelines to meet project milestones and market entry goals.
- Degree in Biomedical Engineering, Regulatory Affairs, or a related field.
- 3+ years of experience in regulatory affairs within the medical device industry, preferably with Class III devices.
- In-depth knowledge of MDR, FDA 21 CFR Part 820, and ISO 13485 standards.
- Strong understanding of technical documentation and regulatory submission processes (e.g., 510(k), CE Mark).
- Excellent organizational skills with a high level of attention to detail.
- Proficient in English; German proficiency is an advantage.
- Positive, adaptable, and able to work in a fast-paced startup environment.
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