Lead QA/RA at a Fast-Growing MedTech Pioneer – Drive Innovation, Compliance, and Impact.

Haeger & Carlsson is proud to partner with SciBase, a global medical technology company, in the recruitment of their next Director QA/RA (Quality Assurance & Regulatory Affairs).

This is a high-impact role for a strategic, hands-on QA/RA leader who is ready to make a real difference. You will take the lead in ensuring regulatory excellence, operational compliance, and continuous quality improvement across the organization.

As Director of QA/RA, you will be responsible for SciBase’s Quality Management System and overall regulatory strategy, including post-market activities, supplier quality, and new product introductions. Working cross-functionally with R&D and Production, you’ll ensure that quality is integrated into every stage of development and operations. Your ability to bring structure, clarity, and proactive solutions will be critical in safeguarding compliance while enabling innovation and patient safety.

At SciBase, you’ll join a collaborative and fast-moving environment where innovation thrives, leadership is hands-on, and trust and transparency guide the way forward. The atmosphere is energetic and supportive – a place where your contributions truly matter. This position reports to the CEO and is based at SciBase headquarters in Sundbyberg, Stockholm.

SciBase is dedicated to improving early detection and prevention in dermatology. The company’s core product, Nevisense, is a unique point-of-care platform combining artificial intelligence and electrical impedance spectroscopy (EIS) to enhance diagnostic accuracy and support proactive skin health management. With a foundation of over 20 years of research from the Karolinska Institute, SciBase is a pioneer in noninvasive diagnostics. The company is listed on the Nasdaq First North Growth Market and is currently launching Nevisense V, the next-generation platform optimized for both clinical and research use. 

Key responsibilities

• Support the organization in building, maintaining, and continuously improving an effective and compliant Quality Management System (QMS). Ensure that all activities within the scope of the role adhere to internal quality protocols.
• Act as the official Person Responsible for Regulatory Compliance (PRRC) in accordance with MDR (EU) 2017/745 Article 15.
• Represent QA/RA at leadership level and ensure management is informed of quality system performance and regulatory priorities.
• Lead QA/RA planning and execution to support timely and compliant market introductions of new products.
• Ensure compliance, risk control, and supplier quality through systematic assessments and collaboration.
• Secure product quality throughout the product lifecycle, from manufacturing to post-market performance.
• Actively collaborate in product development to ensure that quality and regulatory standards are met from the early design stages through commercialization.

Key qualifications

• A university degree, preferably in life sciences or a related field
• Solid experience in independent quality and regulatory work, closely linked to R&D and manufacturing within a medical device company
• Extensive experience ensuring compliance with MDR 2017/745 and ISO 13485
• Experience working with Class I, II, and III medical devices according to MDD/MDR
• Experience collaborating with MDR-related authorities such as Notified Bodies, the European Medicines Agency (EMA), and the FDA
• Experience in participating in both internal and external audits, including those by regulatory authorities such as Notified Body audits, EMA audits and FDA inspections
• Strong cross-functional collaboration skills, including close cooperation with the management team
• Excellent communication skills in both Swedish and English, fluent in spoken and written language

Welcome to apply through haegercarlsson.com

Questions are answered by:

Anna Emterling, Sr Recruitment Manager

+46(0)76-3130137

anna.e@haegercarlsson.com