Amarjit Jowandha Email & Phone Number | A skilled leader, proven strategist, proficient communicator, expert team builder, and adept negotiator who blends expertise in GLOCAL (Think Global, Act Local) QA, RA & compliance (QRC) mgmt. with special skills in Global Market Access (Health Economics and Reimbursement) & Policy, Due Diligence, M&A, Bus. Dev. & Ops. Mgmt. Demonstrated ability to analyze global trends and develop and deploy optimal solutions that improve competitive performance, strategic value, compliance, process & service quality in alignment with corporate objectives and budgetary commitments. => Hands-on professional with 17 years of experience in life sciences industry {Class I-III/IV and Lists A-D, etc.} in a wide range of Therapeutic, Biomaterial (including HCT/Ps, Polymeric & Resorbable) and MedTech (Software-driven electro-mechanical/MEE/MES; MDx & POC; Combination - Pharma/Device/Biologic) areas. => Achievement of health economics and outcomes research (HEOR), 510(k) clearances, PMA approvals, CE-Mark, Health Canada MDL, Japanese PMDA Ninsho & Shonin, and other int'l product registrations (BRICKTM, EMEA, Latin America). => In-depth and hands-on experience with formulation and realization of global quality, regulatory and compliance strategies, processes and systems [21 CFR 3-1271 (incl. QSR), ISO 13485, EU IVDD / MDD, CMDCAS, Fraud & Abuse Laws, Sunshine Act]. => Proven interfacing with BSI, Chinese/Korean/Saudi/US FDA, CMS, DOJ, Intertek, OIG, PMDA, TPD, TNO, TUV & UL toward global compliance and product approval, clearance & certification. => Professional certifications include ASQ’s Certified Quality Auditor (CQA-Biomedical’2003), PMI’s Project Management Professional (PMP’2003), RAPS’ Regulatory Affairs (RAC – EU & US’2003) & SOCRA’s Certified Clinical Research Professional (CCRP’2003). => Proven ability to manage global programs, HEOR, reimbursement & market access. Strong analytical, leadership, mathematical & organizational skills.

Amarjit Jowandha

A skilled leader, proven strategist, proficient communicator, expert team builder, and adept negotia...
Parsippany, New Jersey, United States

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Amarjit Jowandha’s Email amarjit.jowandha@sony.net

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Amarjit Jowandha’s Location Parsippany, New Jersey, United States

Amarjit Jowandha’s Current Industry Sony

Amarjit Jowandha’s Prior Industry Neomedix | Diagnostica Stago | Life Sciencespgsi | Ernst And Young | Ongc

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Work Experience

Sony

Head, Global Quality Assurance, Regulatory Affairs and Compliance (QRC)

2014-06-01 00:00:00 - Present

Neomedix

Senior Director, RA & QA

2011-01-01 00:00:00 - 2013-01-01 00:00:00

Diagnostica Stago

(~VP & Head); Director, RA & QA; Management Representative & US Agent

2013-01-01 00:00:00 - 2013-01-01 00:00:00

Life Sciencespgsi

Sr. Director, Global QA, RA, Compliance & Clinical Affairs; Previously VP, RA/QA; etc.

2001-01-01 00:00:00 - 2011-01-01 00:00:00

Ernst And Young

Sr. Project Manager & Sr. Consultant

1997-01-01 00:00:00 - 2001-01-01 00:00:00

Ongc

DSE(E), Senior Program/Project Manager, Actg. DGM & Head of MSG

1982-01-01 00:00:00 - 1997-01-01 00:00:00

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FAQ About Amarjit Jowandha

Amarjit Jowandha is located at
Parsippany, New Jersey, United States

Amarjit Jowandha is a A skilled leader, proven strategist, proficient communicator, expert team builder, and adept negotiator who blends expertise in GLOCAL (Think Global, Act Local) QA, RA & compliance (QRC) mgmt. with special skills in Global Market Access (Health Economics and Reimbursement) & Policy, Due Diligence, M&A, Bus. Dev. & Ops. Mgmt. Demonstrated ability to analyze global trends and develop and deploy optimal solutions that improve competitive performance, strategic value, compliance, process & service quality in alignment with corporate objectives and budgetary commitments. => Hands-on professional with 17 years of experience in life sciences industry {Class I-III/IV and Lists A-D, etc.} in a wide range of Therapeutic, Biomaterial (including HCT/Ps, Polymeric & Resorbable) and MedTech (Software-driven electro-mechanical/MEE/MES; MDx & POC; Combination - Pharma/Device/Biologic) areas. => Achievement of health economics and outcomes research (HEOR), 510(k) clearances, PMA approvals, CE-Mark, Health Canada MDL, Japanese PMDA Ninsho & Shonin, and other int'l product registrations (BRICKTM, EMEA, Latin America). => In-depth and hands-on experience with formulation and realization of global quality, regulatory and compliance strategies, processes and systems [21 CFR 3-1271 (incl. QSR), ISO 13485, EU IVDD / MDD, CMDCAS, Fraud & Abuse Laws, Sunshine Act]. => Proven interfacing with BSI, Chinese/Korean/Saudi/US FDA, CMS, DOJ, Intertek, OIG, PMDA, TPD, TNO, TUV & UL toward global compliance and product approval, clearance & certification. => Professional certifications include ASQ’s Certified Quality Auditor (CQA-Biomedical’2003), PMI’s Project Management Professional (PMP’2003), RAPS’ Regulatory Affairs (RAC – EU & US’2003) & SOCRA’s Certified Clinical Research Professional (CCRP’2003). => Proven ability to manage global programs, HEOR, reimbursement & market access. Strong analytical, leadership, mathematical & organizational skills.