Holger Reusch
Quality Assurance and Regulatory Manager at Drayson Technologies (Europe) Ltd @Freevolt Technologies Limited
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WORK HISTORY
Quality Assurance and Regulatory Manager at Drayson Technologies (Europe) Ltd @Freevolt Technologies Limited
London and Oxford, GB
Responsible for providing advice and supporting the company to ensure that its software and hardware products and services, through their design, development, manufacturing and marketing, meet internal and external quality assurance, control and regulatory standards.Achievements to date;• Instrumental in the creation from the ground up of an Integrated Management System, aligned to and recommended for Certification by the Certification Body to- ISO 9001:2015, ISO 13485:2016, ISO 27001:2013 and ISO together with satisfactory completion and publication of the NHS Digital Information Governance IG ToolKit• Ensured the Company’s SaMD (Software as a Medical Device) Products were developed in compliance with the Regulatory expectations• Establishing a Programme and Documented Processes for assuring continued control and management of the Integrated Management System• Actively engaged in getting the Products certified for use in other Geographical Regions such as Canada, USA and Brazil, with adherence to the MDSAP process, plus FDA 510k / 513g
EDUCATION
University
BSc Hons
SKILLS
ABOUT HOLGER REUSCH
Extensive computer systems validation and quality assurance management experience in the Pharmaceutical Industry systems and their use, together with the delivery of Quality driven programmes, which provide added value & increase compliance. These programmes have been developed to ensure compliance and continued compliance with the governing regulatory authorities. Exposure & experience in the Sarbanes Oxley (SOX) regulations. Ability to converse and communicate with German speaking clients. Also responsible for writing a number of Publications, White Papers & Articles for the Pharmaceutical Industry, along with presenting at Pharmaceutical Conferences.SPECIAL TRAINING & SPECIALIST KNOWLEDGE / SKILLS:Trained auditor (both auditor facing & auditing practice), plus Six Sigma / Lean Sigma techniquesGMP, GLP & GCP experience. Involvement in GDP expectationsMHRA Rules & Guidance for Pharmaceutical Manufacturers & Distributors, together with Rules and Guidance for Pharmaceutical Distributors, Falsified Medicines Directive and the Delegated Regulation and familiarity with EU GDP Guideline 94/C 63/03, plus EU Directive 92/95 EECFDA CFR 21, Parts 50, 56, 210, 211, 312, 820 and Part 11GAMP 5, PIC/s, ICH: E6, Q8, Q9 & Q10, Annex 11, ASTM E2500, ISO 9001, 27001, 22301ISO 13485 / 14971 / IEC 62366 / EU Medical Device DirectivesUK & EU Legislation, including HIPPA / Data Protection Act / EU GDPRChange Control, Issue / Deviation and CAPA ManagementITIL Foundation, EU GDPR PractitionerIOSH, Fire Marshall & Basic First AidFamiliarisation & appreciation of the requirements covering product labelling & label claimsSpecialties: Consistent Implementation Approach StrategyBest Practice Current CSLC / SDLC Documentation and Deliverable CreationAbility to ensure global Projects are delivered \'On-Time\' and to Budget and involving a high level of influencing and negotiating skillsPractitioner as well as ability to provide consultancy services
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