Careers

Regulatory Affairs and Quality Assurance Specialist

Location: Munich, Germany or San Diego, California 🇩🇪🇺🇸
Employment Type: Full-time

Are you passionate about making a real-world impact in healthcare? We are a fast-growing, innovative digital health company revolutionizing how visual function is measured. Our flagship product, the Manifold Vision Meter, is trusted by top pharmaceutical companies worldwide to guide drug development and improve patient outcomes. We're looking for a highly motivated and detail-oriented Regulatory Affairs and Quality Assurance Specialist to join our small, close-knit team.

As our Regulatory Affairs and Quality Assurance Specialist, you'll be an essential contributor to our regulatory and quality efforts. You'll work closely with an experienced team, helping to ensure our products meet the highest standards of quality and compliance. You'll be a key part of our global operations, working to maintain our regulatory submissions and quality management systems across multiple countries.

What You'll Do

• Regulatory Submissions: Assist in the preparation, compilation, and submission of regulatory filings (e.g., FDA, EU Notified Body) for our medical devices.
• Quality Management: Contribute to the development, implementation, and maintenance of our Quality Management System (QMS) in compliance with relevant standards (e.g., ISO 13485).
• Documentation: Support the creation and maintenance of accurate and up-to-date technical documentation, design history files, and other quality records.
• Audits: Help coordinate and support internal and external audits.
• Compliance: Monitor changes in global regulations and standards to ensure our processes and products remain compliant.

What We're Looking For

• Bachelor's degree in a relevant field (e.g., engineering, life sciences).
• 2+ years of experience in regulatory affairs and/or quality assurance within the medical device or digital health industry.
• Strong knowledge of global medical device regulations (e.g., FDA 21 CFR Part 820, EU MDR, ISO 13485).
• Experience contributing to regulatory submissions and maintaining quality systems.
• Exceptional attention to detail and strong organizational skills.
• Excellent communication and collaboration skills.

Why Join Us?

• Impact: Your work will directly contribute to groundbreaking medical research and improved patient outcomes.
• Innovation: Be at the forefront of the digital health revolution, working with a product that's truly transforming its field.
• Growth: We're a small, quickly growing company, which means significant opportunities for professional growth and development.
• Culture: Join a supportive, close-knit team that values collaboration, curiosity, and creativity.
• Location: Work in one of two vibrant, global cities. San Diego offers a coastal lifestyle with a year-round mild climate ☀️, while Munich provides a rich cultural experience and is a gateway to the Alps ⛰️.

To apply, please send your resume and a brief cover letter to careers@adaptivesensorytech.com with the subject line "Regulatory Affairs and Quality Assurance Specialist Application." Please indicate your preferred location (Munich or San Diego) in your application.

We are an equal-opportunity employer and value diversity. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.