jeff green

senior quality and regulatory compliance consultant

About

Senior Regulatory Affairs Specialist at Bausch + Lomb ... Quality and Regulatory Affairs consulting: Medical Device, Diagnostic , Biotech and Pharmaceutical...

Country

united states

City

apex

Industry

medical devices

Skill

fda, medical devices, gmp, capa, regulatory affairs, quality system, quality auditing, quality assurance, pharmaceutical industry, biotechnology, iso 13485, cross functional team leadership, validation, v&v, design control, iso, 21 cfr part 11, u.s. food and drug administration, quality control, computer system validation, start ups, change control, corrective and preventive action, biopharmaceuticals, glp, verification and validation, qsr, training, iso standards, document management, good laboratory practice, process validation, consent decree, diagnostic

Experience

vice president

edward weck

1974-1 - 1986-1 · 12 yrs 1 mo

ra and qa compliance sme

propharma group

2014-9 - 2015-1 · 5 mos

compliance sme

qualityhub, inc.

2014-5 - 2014-8 · 4 mos

regulatory consultant

ellissen consulting gmbh

2014-4 - 2014-5 · 2 mos

senior medical device quality and regulatory consultant

quantic group

2009-6 - 2013-2 · 3 yrs 9 mos

Contract consulting with Pharmaceutical, Biopharmaceutical and Device companies as an GMP, QSR QSIT, and Regulatory Excellance expert.

senior quality consultant

validant

2008-3 - 2009-12 · 1 yr 10 mos

senior quality and regulatory consultant

rca

2008-1 - 2009-1 · 1 yr 1 mo

Senior Quality and Regulatory contract consulting

senior quality and regulatory consultant

iqvia

2007-1 - 2008-1 · 1 yr 1 mo

Consent Decree remediation International

senior compliance consultant

iqvia

2006-1 - 2006-1 · 1 mo

Senior Quality and Regulatory contract consultant for an Global Manufacturig company in Malmo, Sweden.

corporate director quality and regulatory

the tech group

2000-1 - 2005-1 · 5 yrs 1 mo

vice president qa and ra

eclipse surgical

1996-9 - 2000-9 · 4 yrs 1 mo

Company Officer, Vice President Quality and Regulatory Affairs

vice president qa and ra

dade diagnostice

1990-7 - 1995-9 · 5 yrs 3 mos

Vice President Quality and Regulatory Affairs

quality manager :international

baxter international inc.

1968-1 - 1978-1 · 10 yrs 1 mo

vice president qa and ra

alphatec spine

2006-8 - 2007-3 · 8 mos

Company Officer; responsibilities for the Quality Compliance and Regulatory Affairs Departments

vice president

smith & nephew

1990-1 - 1993-1 · 3 yrs 1 mo

regulatory compliance subject matter expert

depuy/synthes

2013-1 - 2015-5 · 2 yrs 5 mos

Senior Quality and Regulatory contract consultant in Corporate Regulatory Compliance

president and owner and principal consultant

daybreak solutions

2005-1 - Present · 21 yrs 9 mos

* Quality and Regulatory Affairs consulting: Medical Device, Diagnostic , Biotech and Pharmaceutical Industries. * Specializing in FDA Compliance, QSR, QSIT, ISO certitication and CE marking. * CAPA compliance * Training * Management responsibilities * Regulatory submissions * Warning letter remediation and response * Consent Decree remediation * FDA interaction

senior quality and regulatory compliance consultant

bausch + lomb

2016-5 - Present · 10 yrs 5 mos

Bausch + Lomb, a Valeant Pharmaceuticals International, Inc. company, is a leading global eye health organization that is solely focused on protecting, enhancing, and restoring people's eyesight. Our core businesses include ophthalmic pharmaceuticals, contact lenses and lens care products, and ophthalmic surgical devices and instruments. We globally develop, manufacture and market one of the most comprehensive product portfolios in our industry, which are available in more than 100 countries.