Quality and Regulatory Affairs Manager

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

We leverage cutting-edge research to develop drastically better solutions for the greatest challenges to brain health.

Mission-driven and with extensive international experience in MedTech, neuroscience, and AI, we have swiftly raised significant public and private capital and are currently at the most exciting point in the life of a startup: launching the moonshot. Help us build the business and grow the team to advance our innovations and bring them to the masses.

Tasks

YOUR ROLE: Regulatory Affairs Manager

You will oversee and own all aspects of regulatory and medical affairs, helping us to navigate clinical trials, certification, quality management, and market approval (in the USA). You will work together with the teams to ensure compliance with documentation, standards and regulations, timelines, and resources for required testing, and own the interaction with our Regulatory Affairs advisors and partners.

For that, we believe it is good to co-locate with the team in Vienna, Austria but we value performance and value-creation over facetime.

WHAT YOU WILL DO: Own all aspects of RA for an innovative MedTech/Neuro Startup

• Manage partnerships with high-class academic collaborators, CROs, and other partners to ensure swift process navigation for clinical trials and validation testing
• Define and supervise processes for compliant and effective product development and market approval
• Work within medical regulatory requirements (FDA, ISO, IEC) and ensure compliance with standards such as ISO 13485 as well as IEC 60601-1 or ISO 14971
• Own all Quality Management aspects and work on document preparation, information management, file maintenance, and coordination of tasks across multiple departments
• Constantly monitor applicable laws and regulations to determine impact on company activities
• Ensure sustainable implementation of regulatory requirements taking other business and markets aspects of a young, thriving startup into account
• Closely collaborate with engineering and founding members
• Develop certification strategies to enter the US market and analyze the best routes and options
• Be the primary contact for authorities and similar relevant stakeholders
• Support grant applications (European level)

Requirements

YOUR PROFILE: Drive & Ownership

Must-have s

• Min. 3 years Regulatory Affairs Manager work experience in regulated MedTech environment
• Demonstrated professionalism such as an outstanding academic degree, especially in biomedical engineering or related fields
• Experience with (Medical) Quality Assurance Process, Audit and Control and testing
• Experience in product release of at least one medical product to US market (IEC60601, ISO 13485)
• Proficiency in data management and professional documentation
• High attention to details
• Interpersonal skills
• Solutions-driven personality and can-do attitude
• English proficiency

Nice-to-have s

• Work permit for Austria
• Experience with 510(k) submissions
• Clinical research experience
• 2+ years leading Quality Assurance Process in MedTech industry
• Extensive knowledge of applicable MedTech regulations (in the USA) & the ability to stay up2date

Benefits

YOUR BENEFITS: Gain deep and hands-on Regulatory Affairs experience in the vivid and fast-growing field of neuromodulation with personalized and highly innovative solutions

• Be at the forefront of the NeuroTech industry
• Ride a steep learning curve
• Access world-class mentors
• Earn equity and create value for your own
• Enjoy the advantages of a meritocracy with regards to days off or working hour schedule
• Co-locate with ergometric furniture in exciting office prime location in the city center of Vienna
• Enjoy free coffee, brainfood, drinks, and brain stimulation experiments ;-)

This is a unique opportunity to join an early-stage venture to advance 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.

Joining us is more than saying yes to making the world a healthier (and exciting) place. It s unlocking a career in an outstandingly exciting industry - a nucleus of what is to become a globally important company. At Brightmind-AI you will join a culture driven by excellence that helps you not only meet your goals, but also create new ones.

ABOUT US: Private and public capital-backed technology enthusiasts

Brightmind-AI is an Austrian MedTech startup founded in 2022 that brings clinically proven, self-learning neuromodulation to everyday life. With its closed-loop non-invasive brain stimulation technology, Brightmind-AI personalizes stimulation and continuously improves the efficacy of therapies to the central nervous system. The competitive advantage is based on this continuous learning cycle and proprietary designs of an effective stimulation technique.

We are an equal-opportunity employer and value diversity. We consider all applications equally regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. We strongly encourage individuals from groups traditionally underrepresented in tech to apply.