Michael Locke Email & Phone Number | Extensive experience in the Medical Device/Diagnostic manufacturing industry; comprehensive understanding of regulations: FDA CFR 21, cGMP & GLP; CE Marking & EU Directive(s) 93/42/EEC, 98/79/EC & IVDR; ISO 13485, 14971 & 2859-1; Canadian Medical Device Regulations (CMDR/CMDCAS). In-depth knowledge of laboratory techniques, inventory control, biological purchasing & production. Excellent organizational, data collection and reporting skills. Effective leader, teacher, and planner. Specialties: •Preparation of regulatory submissions to FDA, Notified Bodies, or other regulatory authorities; •Proven ability to think strategically, to deal with complex or ambiguous issues; •Ability to communicate and interact effectively across all levels of the company; •Proven ability to solve complex problems and make appropriate regulatory decisions; •Ability to balance multiple responsibilities on-time and effectively;

Michael Locke

Extensive experience in the Medical Device/Diagnostic manufacturing industry; comprehensive understa...
New York City Metropolitan Area, New York City Metropolitan Area, United States

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Michael Locke’s Email michael.locke@euroimmun.us

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Michael Locke’s Location New York City Metropolitan Area, New York City Metropolitan Area, United States

Michael Locke’s Current Industry Safeguard Biosystems

Michael Locke’s Prior Industry Sebia | Perkinelmer | Euroimmun Us A Perkinelmer | Immunostics | Cenogenics Laboratory Diagnostics

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Work Experience

Safeguard Biosystems

Head Of Regulatory Affairs & Quality Management

2021-08-01 00:00:00 - Present

Sebia

VP Regulatory Affairs & Quality Management

2022-08-01 00:00:00 - 2023-06-01 00:00:00

Perkinelmer

Sr. Director Regulatory, Quality & Medical EMEAI

2020-01-01 00:00:00 - 2021-03-01 00:00:00

Euroimmun Us A Perkinelmer

Director Of Regulatory Affairs & Quality Management

2013-03-01 00:00:00 - 2020-01-01 00:00:00

Immunostics

Director of Regulatory Affairs & Quality Management

2008-04-01 00:00:00 - 2015-04-01 00:00:00

Cenogenics Laboratory Diagnostics

Regulatory Affairs/QC & QA Analyst

2002-08-01 00:00:00 - 2008-04-01 00:00:00

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Languages

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FAQ About Michael Locke

Michael Locke is located at
New York City Metropolitan Area, New York City Metropolitan Area, United States

Michael Locke is a Extensive experience in the Medical Device/Diagnostic manufacturing industry; comprehensive understanding of regulations: FDA CFR 21, cGMP & GLP; CE Marking & EU Directive(s) 93/42/EEC, 98/79/EC & IVDR; ISO 13485, 14971 & 2859-1; Canadian Medical Device Regulations (CMDR/CMDCAS). In-depth knowledge of laboratory techniques, inventory control, biological purchasing & production. Excellent organizational, data collection and reporting skills. Effective leader, teacher, and planner. Specialties: •Preparation of regulatory submissions to FDA, Notified Bodies, or other regulatory authorities; •Proven ability to think strategically, to deal with complex or ambiguous issues; •Ability to communicate and interact effectively across all levels of the company; •Proven ability to solve complex problems and make appropriate regulatory decisions; •Ability to balance multiple responsibilities on-time and effectively;

Michael Locke currently works in the Safeguard Biosystems |

No Languages Available

Michael Locke has prior
experience in the following industries:
Sebia | Perkinelmer | Euroimmun Us A Perkinelmer | Immunostics | Cenogenics Laboratory Diagnostics

Michael Locke has the following professional experience:
Safeguard Biosystems | Sebia | Perkinelmer | Euroimmun Us A Perkinelmer | Immunostics | Cenogenics Laboratory Diagnostics