Martin King
Selbstständig, Hands-on Senior Regulatory Affairs & Quality Assurance Professional, Medical Devices, In-Vitro Diagnostics, Pharmaceuticals , QA/RA
Zug, Schweiz
Werdegang
Berufserfahrung von Martin King
Bis heute 4 Jahre und 1 Monat, seit Mai 2020
Hands-on Senior Regulatory Affairs & Quality Assurance Professional
Medical Devices, In-Vitro Diagnostics, Pharmaceuticals , QA/RA
Hands-on Regulatory Affairs & Quality Assurance Expert with over 20 years in pharmaceutical & medical device industries. Specializing in best-practice regulatory submissions (USA, EU, UK, MENA, ASEAN, Americas) and ISO compliance, risk management etc. Always ready to help where I can. m.king@bluewin.ch
1 Jahr und 9 Monate, Aug. 2018 - Apr. 2020
Director Quality Assurance Regulatory Affairs, Interim COO
Weibel CDS AG
Customer facing, Quality and Regulatory Compliance of wearable precision drug delivery systems and Advanced Safety Syringes with Closed System Drug Transfer and Reconstitution/Compounding. Development and commercialisation of Flexible Form primary drug container for low profile large volume wearable injectors, High Viscosity small form factor patch Injectors and pumps, Advanced Safety Syringes, Drug Delivery with Automated Drug Reconstitution.
1 Jahr und 11 Monate, Sep. 2016 - Juli 2018
C-Level Interim Medtech / Pharma operational leadership, management, QA/RA
Interim Consulting
Global experience working the complete Pharma/Medtech Value Chain end-to-end Development through to Commercialisation: Self-test/use Combinational Drug & IVD Platforms, Advanced Safety Syringes, Automated Drug Reconstitution, Drug Delivery (High Volume, High Viscosity patch Injectors and pumps) and IVD Devices. Supporting broad range of needs in Quality Assurance & Regulatory Affairs (GxP, ISO 13485:2016, ISO 15378:2015, ISO 10993:2018, ISO 14971, IEC 62304:2016, ISO 9001:2015, ISO MDR 2017/745, 2017/746).
8 Jahre und 2 Monate, Juli 2008 - Aug. 2016
CEO Chief Executive Officer & Deputy Swissmedic QP
Anstar AG
Established organisation, registered and launched a portfolio of contract manufactured premium oncology generic pharmaceutical products. (Solid, Liquid, Lyophilisat dosage Forms). Transferred Manufacturing to local manufacturing sites. Organised preclinical Studies and Phase 1 Trials of an original product for pulmonary therapy and treatment. Audited and Setup contract Manufacturing, Managed cross-border compliance matters. Audited and negotiated with Distributors and Logistics Carriers.
1 Jahr und 8 Monate, Sep. 2006 - Apr. 2008
Head of Biocontrol (Automation)
Bioengineering AG
• Coaching & Team Building for Hardware & Software systems development & Commissioning • Introduction new process automation development life cycle. • Introduction of Service Packages and Service Level Agreements. • Logistics coordination for machine automation around the globe. • Managing and coaching key customer accounts and Projects with representative offices in North America & Asia Pacific.
Consultant
Martin King
CEO
Quick Com AG
Vice President
Fantastic Corporation
R & D Manager Wirebonder
ESEC
Senior Engineer
Landis & Gyr
Senior Research Officer
N.I.M.R., London
Ausbildung von Martin King
1 Jahr und 10 Monate, Sep. 1989 - Juni 1991
Microelectronics and Materials Science
Middlesex Polytechnic London
Microelectronics, Materials Science
MBA
Herriot Watt, Edinburgh
Finance and Marketing
Sprachen
Deutsch
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Englisch
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Französisch
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Russisch
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