Experience

PETER BREHM GmbH

• Germany
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Person Responsible for Regulatory Compliance (PRRC)

  • May 2020 - Present

• Head Of Regulatory Affairs

  • Jan 2019 - Present



Resorba Medical GmbH / Advanced Medical Solutions

• Manager Regulatory Affairs

  • Jul 2016 - Dec 2018

  Personnel responsibility, Budget responsibility, Responsibility for 27 product files (18 class III, implants, including combined medical devices and animal origin, the rest are class I - IIa and IIb), Establish priorities; contact person for regulatory issues throughout the company and with customers, IFUs, post-market surveillance, preparation and maintenance of design dossiers and technical documentation, implement new regulations, resolve conflicts and accept new challenges, adherence to deadlines, approval strategy for new products, project management, international registrations, risk management, quality management, recertification, internal auditor, monitoring of audits



Biocer Entwicklungs-GmbH

• Germany
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Regulatory Affairs Manager

  • Feb 2016 - Jun 2016

  Preparing and maintaining the technical product documentation (STED structure, risk classes IIb and III); Cooperation with authorities and notified bodies; Regulatory strategy for new products; contact with international distributers; Providing documentation for international registrations; Planning, implementing and evaluating of audits, contact person for all regulatory issues; Preparing QM-documents; Project management; Capturing national and international laws, regulations and directives (Medical Devices)



Tutogen Medical GmbH / RTI Surgical

• Compliance Manager

  • Jul 2014 - Jan 2016

  Deputy to the Head; Tissue, Medical Devices class III (animal origin), Pharmaceuticals (tissue human origin); Quality Management; Regulatory Affairs - Capture, implementation and communication of national and international laws, regulations and directives (Tissue; Drugs and Medical Devices class 3); Development of concepts contract (supply, Quality Agreements, etc.); Support in the planning, execution and reporting of audits; Cooperation with authorities, associations and external organizations; Project management; Preparing QM-documents; Product Quality Review, GMP, internal auditor

• Manager Regulatory Affairs

  • May 2013 - Jun 2014

  Medical Devices class III (animal origin), pharmaceuticals (tissue human origin), Tissue, project management, GMP, national authorization of medicinal products (human tissue preparations); Life Cycle Management (Variations module 1 and 3 of CTD, Renewal); Preparation, implementation and follow up of inspections and audits (Drugs and Medical Devices class 3); legal requirements; regulatory strategy for new products; Quality Management; contact with authorities; Product Quality Review; Transition to eCTD; Scientific Advice (highest federal competent authority (PEI); ATMP yes or no)



University hospital Erlangen-Nuremberg

• research fellow (Post-Doc)

  • Sep 2011 - Aug 2012