Regulatory affairs new
The candidate will be a pivotal part of our team, responsible for registration and regulatory approvals of Methink’s products. Will also be 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 and FDA 510(k)
- Experience in Quality Control systems (ISO 13485) and FDA QSR (21 CFR 820)
- Ensure compliance with privacy regulations (GDPR & HIPAA)
- Design and execute trials for regulatory approval
- Write and maintain user manuals for our products
- Experience in the medical device regulatory environment
- Exposure the process of registering Software as a Medical Device (SaMD) would be particularly desirable; however, given the relative infancy of the Digital Health market, will also consider people with wider Medical Device experience
- 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:
- Team: be part of a solid team with an extensive experience, passionate about their work and capable to bring cutting-edge technology to market.
- Flexible work-life balance: we are focused in performance and everybody has different ways to achieve it. We make our best so that our colleagues feel comfortable in their work environment.
- Progression: We are an early stage company with a multidisciplinary team. We offer the opportunity to people to grow together with the company.
- Equal Employment Opportunity: We proudly pursue a diverse workforce and we don’t make any hiring or employment decisions that could be discriminatory in any way.
- Benefits: Fee discount at a leading sports center in front of the sea, at a 15min walk from our offices.
- Workplace: Pier01 in Barcelona, overlooking the Mediterranean Sea in Port Vell.
- Annual compensation: 25k-40k + milestone bonus