Stefan Scheib Email & Phone Number

Munich, By, De

Key interface in translating customer and business needs, as well as strategy on severallevels into clear priorities for Regulatory Affairs. Closely working with the Core Lab Customer Area Business Teams, Functional Partners, Lifecycle Teams and across Networks to deliver comprehensive and successful Customer Solutions.Development of global regulatory strategies that weigh the requirements of all regions, solutions that maintain compliance while helping to advance the customer needs.Member of the Regulatory Affairs Leadership Team.

Responsible for IVD-submissions and maintenance of a complete product line (Heterogeneous Immuno Assays; about 100 existing assays). Regions: EU, US, China, Japan in cooperation with local affiliates, all classes of products.People leader, creating an effective team out of three different groups.Representing the team in internal management teams.Since January 2016: additional responsibility for other regions (APAC, Latam, Canada).Direct contacts with Health Authorities and Notified Bodies.Divisional regulatory representative for the internal global UDI (Unique Device Identification) project.

Leading a small team for submission of mainly Hepatitis assays (IVDs).Focus: Europe and US (Design Dossiers and PMAs).Direct authority contact, project management.Divisional regulatory representative for the internal global UDI (Unique Device Identification) project.

Harmonization of the change control processes after merger of two business areas.Project lead of an internal SAP project for introduction of a new change control software.Heading several change boards.Internal and external (supplier) audits/inspections as lead auditor. Running the back office in several FDA-inspections, audit escort and audit organisation for various authorities.Review and approval of Qualification/Validation documentation.

Responsible for the business processes equipment qualification and archiving of technical documents for production equipment.Establishing a new group within the site management department (hiring people, defining responsibilities and services, establishing the new service/group on the site).Ran several qualification projects, some of them for new large biotechnical manufacturing buildings.Introduction of a new SAP document management system.

04/00 to 04/01: Head of Qualification -- 08/99 to 04/00: Plant Manager (Deputy of Head of Operations) -- 06/97 to 07/99: Project Lead Scale-Up (Process Development) - all in the Chemistry Department (API production).Certified Six Sigma Black Belt.

Post Doc, Organische Chemie

Promotion, Chemie

Diplom, Chemie