Regulatory affairs specialist
Will be an integral part of a small team of people, responsible for registration and regulatory approvals of Methink’s products. Will also responsible for grants, subsidies and quality control systems. The right candidate will have good analytical and writing skills, be willing to prepare appropriate documentation for different audiences, capable of solving problems in a startup environment, looking to improve health care in the world, and save lives!
We are looking for someone that can/has:
- Understand and design regulatory strategy for our products
- Prepare and maintain regulatory approvals, for CE Mark IIA and FDA 510(k)
- Experience in Quality Control systems (ISO 13485)
- Design and execute trials for regulatory approval
- Write and maintain user manuals for our products
- Experience in the medical device regulatory environment
- Prepare and follow-up of grants or government subsidies
- None of the above but a good sense of humor and readiness to learn
Benefits/what we can offer:
- Workplace: Pier01 in Barcelona, overlooking the Mediterranean Sea in Port Vell
- Annual compensation: $20K - $30K per year, and milestone bonuses.
If interested, please fill in the form: https://goo.gl/forms/Yuciyy47x0EgebK72