Experience

Sempermed

• Austria
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Senior Manager Contracts and Regulatory Affairs

  • Mar 2020 - Present

  • negotiation of business agreements on medical devices and personal protective equipment together with business partners (mainly: product,- regulatory affairs or quality management related)• organize the contract mangement process from creation to filekeeping • advise on legal, regulatory and quality related content• Manage Sempermed's trademark portfolio and advise on trademark matters• functional team lead for the contract managers in other sites • QM/ RA Project Management and Change Management; MDR Project Lead • manage selection & work of QM/ RA supplieres (notified bodies, country rep's (e.g. CH), lawyers, US Agents)• review/ release product,- regulatory or quality related documentation and marketing material • support external audits for ISO 13485, MDR conduct internal and supplier audits • FDA setup including establishment registration, device listing and other US regulatory matters Show less

• Reglatory Affairs Manager

  • Jul 2016 - Feb 2020

  in the business segment SEMPERMED - manufacturer of medical (Class I, Is, IIa) and protective gloves. • Product registration for medical gloves in the CE area, US, APAC, LATAM and other countries;• monitor legal and regulatory requirements & initiate changes • review/ release of all product relevant information (e.g. labelling, declarations of conformity, marketing material)• management of all external RA consultants • management of RA budget• teamlead • Project lead "Implementation of the Medical Device Regulation 745/ 2017 (EU) Show less



Semperit AG Holding

• Legal Counsel

  • May 2008 - Jun 2016

  Legal Management of the Segment SEMPERMED (medical gloves) and (until 2013) SEMPERFLEX (hydraulic and industrial hoses) with worldwide responsiblity. responsible for all operational legal topics such as drafting and negotiating various contracts for sales and purchasing Commercial litigation trademarks and IP management and litigation Legal claim management Insurance Corporate reorganisation Legal management of factory expansion projects Legal Management of the Segment SEMPERMED (medical gloves) and (until 2013) SEMPERFLEX (hydraulic and industrial hoses) with worldwide responsiblity. responsible for all operational legal topics such as drafting and negotiating various contracts for sales and purchasing Commercial litigation trademarks and IP management and litigation Legal claim management Insurance Corporate reorganisation Legal management of factory expansion projects



Prisma Kreditversicherungs-AG

• Account-Manager

  • Jan 2007 - Apr 2008

  Acquisition of new customers for trade credit insurance Acquisition of new customers for trade credit insurance



coporate lawfirms in Vienna

• legal counsel (not yet admitted to the bar)

  • Aug 2003 - Jul 2006

  legal advise in commercial law, representation of clients in court, arbitration proceedings legal advise in commercial law, representation of clients in court, arbitration proceedings