Mia Andersen

Mia Andersen has extensive experience in the field of quality management and regulatory affairs. Mia'smost recent position was as the Head of RA/QA at Dawn Health, where they were responsible for overseeing three teams and setting the strategic direction for RA/QA/CA. Prior to this role, Mia worked at Radiometer as a Senior Manager of Customer Complaints & QMS Compliance, where they successfully managed customer complaints and ensured compliance with quality management systems. Mia also held the position of Manager of QMS Compliance and QA Specialist at Radiometer.

Mia has also been involved in the Danish MedTech Society as a Board Member, where they focused on medical device development and supported accounting efforts. In previous roles, they worked at UNEEG medical A/S as a QMS Manager and RA/QA Specialist, where they handled quality assurance, regulatory affairs, and maintained ISO 13485 certification.

Mia has experience in medical device compliance engineering, having worked as a Medical Device Compliance Engineer at ALK Abello. Mia ensured compliance with regulations and standards in the development of medical devices and combination products.

Mia began their career at DELTA, where they gained foundational experience as a Student Worker and later as an Engineering Intern. In these roles, they were responsible for ensuring the use of the correct standards in EMC test reports and communicating with customers. Mia also gained exposure to regulatory areas, particularly in medical devices and electrical equipment.

Overall, Mia Andersen has a strong background in quality management, regulatory affairs, and medical device compliance, with experience in a variety of roles and responsibilities.

Mia Andersen's education history begins in 2011 when they enrolled in Aarhus University School of Engineering. Mia completed their studies in 2015 and obtained a Diploma Engineer degree in Healthcare Technology. In the same year, Mia also obtained a certification in Compliance with Medical Device Directive 98/42/EEC (MDD) from Cameron Quality Consultants.

Mia's education continued in 2015 when they enrolled in Aarhus University School of Engineering again. This time, they pursued a degree in Business Engineering, which they completed within the same year. As part of their education, Mia also obtained a Lean Six Sigma - Yellow Belt certification from Game Change Lean Six Sigma Training and Consulting.

Outside of their formal education, Mia has obtained several additional certifications. In 2016, they obtained a certification in Risk Management for medical devices and ISO 14971 from Gantus AB. The following year, they obtained a certification as a Biological Safety Specialist from NAMSA. In 2017, Mia obtained a Lead Auditor (ISO 13485:2016) certification from IQC (Irish Quality Centre), and in 2018 they obtained a certification in FDA Quality System regulation, 21 CFR 820 from AAMI. Most recently, in 2022, Mia obtained a certification in Clinical Evaluation from Medidee.