Lucerne Metropolitan Area
Some people see regulatory requirements as nothing more than red lights. I see them as guard rails that enable a company to safely enter new markets at top speed. For me, the world of regulatory affairs is not about simply collecting stamps, but about translating paragraphs into tangible market advantages. My approach is pragmatic: instead of admiring complexity, I build bridges between legal requirements and business growth. Why do I enjoy doing this at the interface between Switzerland and Sweden? Because both cultures share a deep passion for precision and quality. I help channel these values so that regulatory hurdles become a springboard rather than a stumbling block. When I'm not untangling complex regulatory frameworks, you'll probably find me trying to strike the perfect balance between efficiency and serenity – or talking shop about the next technological wave. Because at the end of the day, technology (and the law) should work for us, not the other way around.
Arcomed AG designs, develops and manufactures infusion pumps for intravenous applications and distributes medical class IIa consumables and class IIb Devices. • Expansion of our quality management system according to ISO 13485 • Management and support of QM-relevant projects • Creation of vigilance, CAPA and post market surveillance processes • Conducting internal audits and preparing for re-certification/re-certification and surveillance audits • Supervision of process and document changes within the scope of the quality management system • Holding internal training courses for quality assurance • Planning and execution of audits of all kinds (worldwide) (ISO, FDA, MDSAP) • Maintenance of technical documentation structure for the MDR certificate • Preparation of the entire approval procedure (technical documentation up to apostille maturity) • Support in the selection of suppliers of consumables around the world • Establishment and expansion of a ProAlpha controlled process network including qualification and validation (Software-Validation) • Execution of validations (DQ-IQ-OQ-PQ) and preparation of risk analyses Risk-Management • Usability Engineering-Process & Use Design Risk Assessment etc. • Introduction of FDA-conform review and qualification processes - Certified TQM- of the consumer goods industry - Certified QM specialist for medical technology - Certified auditor for medical technology - Certified QM consultant for medical technology -Certified Regulatory Affairs Manager for medical technology Standards areas: > Food and Drug Administration (FDA) > ISO 13485:2016 (medical device manufacturing) > MDR: Medical Device Regulation > MDSAP (Medical Device Single Audit Program) > Risk management standard ISO 14971 > IFS (International Food Standard) > BRC (British Retail Consortium) > ISO 9001:2015 & ISO DIN EN 15224 > ISO 14001 environmental management > Software validation (GAMP5)
Boneartis designs, develops and manufactures bone replacement implants and materials for human bone reconstruction. • Production management of the two production sites in Brunnen. • Carrying out internal and external audits • Preparation of all QMS documentation • Documentation and execution of equipment qualification, sterilization, medical devices, CCs • Deviation and CAPA management • Instructions for test methods, material analysis, technical documentation, regulatory Affairs • Process validation plans and reports • Creation of manufacturing specifications, standard instructions. • Strategic business planning • Personnel management • Successful development to ISO13485 certificate
Früh are a market leading packaging CMO for the Medical device, pharmaceutical device and food packaging industries. • Responsible for process optimization in the field of flexible packaging for medical / pharmaceutical devices and food packaging • Preparation of packaging development and manufacturing technical documentation • Participation in customer and supplier audits • Management of customer complaint investigations • Responsible for equipment and tool qualification • Preparation of work instructions and training documents • Cooperation in test series and developments in the field of stamping and forming technology as well as Peel-Pouch for the pharm- Area • Execution of process and product and software validations • Responsible for the personnel management in the production area • Performing tactile 3D measurements • Evaluation of CPK requirements and Q-STAT analysis • Creation of requirements documentation focusing on pharmaceuticals and medical technology • Responsible for the QA documentation and management of the documents • Editing Change-Control and Deviation Reports (8-D Reports) • Creation of SOPs, specifications and validation plans • Project work in the area of flexible packaging for the companies, Roche, Novartis and Genentech
Swiss Caps AG in Kirchberg (today a member of the Aenova Group) is a global company in the field of encapsulation and packaging of hard and soft gelatin capsules for the medical, pharmaceutical and food industries. • Responsible for the training and development of employees • Conducting employee and conflict talks • Organization of the shift group • Development and implementation of continuous improvement processes • Ensuring a smooth production process with regard to quality and quantity • Control of production papers and bookings • Correction of postings in SAP and Hydra • Professional and disciplinary leadership of a shift group of 20 employees