Isabella Moser

Quality Assurance/Regulatory Affairs Manager at Pregnolia

Isabella Moser is the current Quality Assurance/Regulatory Affairs Manager at Pregnolia. Prior to this, they served as the Director of Quality Management & Compliance at Hapa AG from September 2007 to February 2013. In this role, they were responsible for establishing and implementing a process-oriented QMS according to ISO 9001, as well as establishing and integrating ISO 14001 into the established QMS. Additionally, they worked to improve safety to meet the occupational health and safety standards (ASA) for employees in Switzerland (EKAS), and supported compliance with applicable laws, standards, norms and regulatory requirements for the printing machinery and chemical industries.

Since 2013, Ms. Moser has been based in regulatory affairs, FDA, REACH, etc. Isabella has also been responsible for conformity assessment, risk analysis, technical files, internal and supplier audits, KPI control, corrective actions, and continuous improvements. Additionally, they are a member of the change management team and provides training in QM, GMP, regulatory affairs, REACH, auditing, SOPs, and compliance.

After completing a recognized bachelor's degree in business administration and management from KVZ Kaufmännischer Verband, Isabella Moser pursued further education in the field of quality systems management through the European Organization of Quality and SAQ / Qualicon. Isabella also holds a certificate in quality auditing from Consultant Liechtenstein. In addition to their educational background, Isabella is also certified by The European Organization of Quality as a Quality Systems Manager and by SAQ-QUALICON AG as a Quality Systems Manager.

Isabella Moser reports to Sabrina Badir, Founder & CEO. They work with Laura Bernardi - Product Manager/Clinical & Medical Project Manager, Michael Fernandez - Senior Scientist/Technical Product Manager, and Bruno Candrian - VP, Marketing & Sales.

Timeline

  • Quality Assurance/Regulatory Affairs Manager

    Current role