Quality Assurance and Regulatory Affairs
Senior QA/RA Expert
MSc. Chemistry Lund University
Available for: Part-time, full-time
- Project management
- Quality management
- Management Representative
- Gap Analyses
- Quality systems implementation
- Design Control
- Design Dossiers and Technical File forCE marking
- Preparation and submission of int.l registrations for Class IIa, IIb and Class III medical devices and for IVDs.
- Trained Lead auditor; supplier audits, internal audits
- Risk Management, Complaints, CAPAs
- Software Validation
- Change Control
- Management of QA and RA functions in several companies.
- Certification (ISO 13485) of a Swedish site of an international company.
- All development projects deliveredon, or before schedule, as project manager at a large Swedish company
- Took one company from the state of a FDA warning letter and US import detention to a successful FDA inspection resulting in no observation in one year.
- Several international approvals
- Compiled Technical Files for an entire product portfolio for a large Swedish company.
Extensive knowledge in:
- EU Directives: Medical Device Directive MDD 93/42/EC, in vitro diagnostic directive IVDD 98/79/EC
- EU regulations: Medical device regulation 2017/245, In vitro diagnostic medical devices 2017/246
- DA regulations: CFR 21 Part 820, Part 11, Part 803, Part 806
- EU harmonized/internationally recognized standards: ISO 13485, ISO 14971
- MEDDEV guidance: 2.12/1
Is a dedicated person who strongly believes that every problem has (at least) one smart solution. She enjoys working in teams. She has extensive experience in Quality Assurance and Regulatory Affairs, both as manager and hands on. She spends her free time with family and friends, listening to music, reading, yoga and fitness in general.