Bernd Schell

Director of Regulatory Affairs @Baxter International Inc.

Munich, DE
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Dec 2021 — Present

Director of Regulatory Affairs @Baxter International Inc.

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Munich, DE

Global Responsibility to manage the Surgical Solutions medical device portfolio, consisting of Trumpf Medical (Germany - operating tables, operating lights and ceiling pendants), Allen Medical (MA, US - operating table and table accessories) and Videomed (Italy - connectivity software in medical surgical rooms).Lead the Surgical Solutions Regulatory Organization in developing global regulatory strategies and global device registrations with new product development support and full lifecylce management.

EDUCATION

1987 — 1991

Ravensburg-Weingarten University of Applied Sciences

Dipl.-Ing. (FH), Applied Physics

1991 — 1992

Université Savoie Mont Blanc

European Master in Environmental Engineering

SKILLS

Corrective and Preventive Action (Capa)IecQuality SystemQuality SystemsIso StandardsCross-Functional Team LeadershipIso 14971Quality AssuranceAuditingGmpValidationRegulatory SubmissionsMedical DevicesCe MarkingQuality ManagementIso 13485Regulatory AffairsU.s. Food and Drug Administration (Fda)

ABOUT BERND SCHELL

Director of Global Regulatory Affairs Surgical Solutions

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Bernd Schell — Director of Regulatory Affairs at Baxter International Inc. in Munich, DE | Unifers