Regulatory Affairs & QA Manager – Neurotech Medical Device

Millions of people worldwide suffer from brain-related issues, such as migraine & dementia, that can already be addressed with the latest breakthroughs in neurotechnology.

Our client is an Austrian start-up that uses cutting-edge research to develop drastically better solutions for the greatest challenges to brain health. The mission-driven founders have extensive international MedTech, neuroscience, artificial intelligence (AI), and commercial experience. Having swiftly raised significant public and private capital, they are ready to build the business and grow the team to advance their innovations and bring them to the masses.

As a Regulatory Affairs & QA Manager you will be solely responsible for overseeing and owning all aspects of regulatory, QA and medical affairs for a Class IIa Medical Device, helping to navigate clinical trials, certification, quality management, and market approval (in the USA).

You will work closely with the co-founders and a small team of engineers to support product development and market approval. To achieve the close-knit, collaborative working environment, you will ideally be based in, or willing to relocate to Vienna.

Responsibilities

• Manage partnerships with academic collaborators, CROs, etc.
• Ensure swift processing for clinical trials and validation testing
• All regulatory activities e.g. ISO 13485, IEC 60601-1 & ISO 14971
• Quality Management, document preparation and information management
• Develop certification strategies to enter the US market
• Ensure sustainable implementation of regulatory requirements
• Support grant applications (European level)

Requirements

• 3+ years Regulatory Affairs work experience in MedTech hardware
• Biomedical Engineering degree or related field
• Experience with Quality Assurance Process, Audit and Control and testing
• Experience releasing at least one medical product to US market (IEC 60601, ISO 13485)
• English proficiency

Desirable

• Experience with FDA 510(k) submissions
• Clinical research experience
• 2+ years leading Quality Assurance Process in MedTech industry

Benefits

This is a unique opportunity to join an early-stage start-up (& meritocracy) advancing closed-loop non-invasive brain stimulation to address unmet, globally relevant clinical needs. You will join a highly competent team supported by seasoned MedTech experts, outstanding advisors, and world-leading scientists.

As a solution-driven and meticulous Quality Assurance and Regulatory Affairs Manager, you will quickly and effectively lead the process of meeting standards to launch the leading-edge medical device. Your desire to make an impact means you will fit into a team that values intellectual integrity and high-performance, but also likes to have fun at work.

You will be rewarded with a highly competitive compensation and an opportunity to earn equity in a fast-growing HealthTech company.