Regulatory Affairs Specialist - Position Requirements

About the Company

We are a cardiovascular AI company based in Helsinki, Finland, developing innovative AI-powered medical imaging technology. We're conducting international clinical validation trials in partnership with elite institutions to bring our technology to patients around the world.

About the Role

Join us as a foundational member of our regulatory team with a clear path to leadership. This role offers the opportunity to grow into a Regulatory/Quality Manager position as the company scales and our product portfolio expands. You'll build the regulatory infrastructure from the ground up and shape our global regulatory strategy.

Key Responsibilities

• Ownership and Maintenance of our Quality Management System ensuring compliance with ISO 13485 and regulatory requirements

• Work closely with the Clinical Research Manager to support regulatory strategy and clinical trial compliance

• Develop and expand comprehensive SOPs covering:

  • Design controls and product development

  • Clinical trial management and oversight

  • Post-market surveillance and vigilance

  • Document control and CAPA processes

  • Internal audit programs

• Produce technical documentation for FDA and MDR submissions including technical files, clinical evaluation reports, and risk management documentation

• Build quality framework to support multi-site international trials

• Maintain relationships with notified bodies and regulatory authorities

About You

Core Experience (Minimum 3 Years)

• Hands-on experience populating and implementing a Quality Management System (QMS) for medical devices

• Regulatory affairs and/or quality assurance in medical device industry

• Experience with different classes of medical devices (Class I, II, III/IIa, IIb, III) with focus on Class IIa+ devices

• Knowledge of clinical trials from pre-market study through post-market clinical follow-up

• Hands-on regulatory submissions (FDA 510(k)/De Novo or EU MDR)

• Direct experience building or expanding SOPs and quality documentation systems

• AI/software medical devices experience strongly preferred

Required Knowledge

• Proven experience implementing QMS documentation and processes in compliance with ISO 13485

• FDA regulations (21 CFR 820) and EU MDR - practical application experience required

• ISO 13485 (Quality Management Systems for Medical Devices) - hands-on implementation experience

• IEC 62304 (Software Life Cycle Processes) - direct application to software/AI medical devices

• ISO 14971 (Risk Management) - experience creating and maintaining risk management files

• Clinical trial regulatory requirements across multiple jurisdictions

• Technical documentation preparation (technical files, CER, risk management files, design history files)

• Understanding of AI/ML-specific regulatory considerations and software validation requirements

Highly Desirable

• Experience with Good Machine Learning Practices (GMLP) and AI/ML medical device regulations

• Familiarity with IEC 82304 (Health Software) and ISO 62366 (Usability Engineering)

• Knowledge of additional regulatory bodies: LATAM markets, Japan (PMDA), China (NMPA), Australia (TGA)

• Experience with electronic QMS platforms (e.g., Greenlight Guru, MasterControl, Qualio)

Professional Skills

• Detail-oriented with excellent organizational skills and documentation abilities

• Collaborative team player who thrives in a flat organizational structure

• Self-starter capable of managing multiple priorities independently

• Pragmatic approach balancing compliance with business needs

• Strong technical writing and communication skills

Language Requirements

• Fluent English (written and verbal) - required

• Additional languages such as Japanese, Chinese, Spanish, or French are a significant benefit

Education

• Bachelor's degree in life sciences, engineering, biomedical sciences, pharmacy, chemistry, biology, or related technical field (required)

• Advanced degree (Master's or PhD) in regulatory affairs, regulatory science, or related field (strongly preferred)

• Equivalent combination of education and relevant medical device experience will be considered

What We Offer

Career Growth & Impact

As a foundational team member, you'll have a clear path for career development, with the opportunity to grow into a Regulatory/Quality Manager position as our company scales. You'll play a crucial role in building and shaping the regulatory framework of our organization from the ground up, giving you direct impact on company strategy and our global expansion trajectory. As a startup, we believe in fostering career growth and development, offering opportunities to take on more responsibilities, lead teams, and step into management roles as we grow.

Our Culture

We're a diverse team that genuinely values fresh ideas and innovation. Our company culture is open and collaborative we don't believe in long inefficient workdays or a rigid hierarchy. Instead, we value a relaxed and family-like atmosphere where everyone can feel comfortable being themselves. We believe in empowering our teammates to do their best work, and we offer flexible work arrangements to accommodate their needs. Whether you prefer the flexibility of remote work or the energy of our office environment, we provide adaptable working arrangements to suit your lifestyle.

Office & Benefits

Our office is located in the heart of Helsinki at Maria01 campus, one of Europe's leading startup hubs, where you'll have free access to modern gym and sauna facilities, along with complimentary refreshments throughout the day. We believe in fostering a strong, collaborative culture through regular team lunches and social gatherings, creating meaningful connections beyond day-to-day work. Your well-being matters to us, which is why we provide comprehensive health insurance coverage for all employees. With flexible scheduling and no travel requirements, you can maintain the work-life balance that's important to you while contributing to groundbreaking technology that will impact patients worldwide.

Our Commitment to Diversity, Equity, and Inclusion

We believe that diversity fuels innovation and equity drives excellence. We are dedicated to building a workforce that reflects the rich diversity of the people we are building to serve. Our work requires unique perspectives, encourages open dialogue, and ensures equal opportunities for growth and advancement. We're actively working to eliminate barriers in healthcare, and we therefore create a work environment where everyone feels valued, respected, and empowered to bring their authentic selves to work.

At AIATELLA, we're a workplace where diverse perspectives thrive and every team member can make a meaningful impact. We're looking for passionate individuals who see potential in this role, even if their experience doesn't perfectly align with every requirement. If you believe you can contribute and grow with us, we strongly encourage you to apply. We offer development opportunities to help you succeed in this position.

If you want to work on challenging and rewarding projects that have a real impact on people's lives, we want to hear from you. Join us in our mission to save lives through cutting-edge technology!