Daniel Rana

Director, Regulatory Affairs, Emea & Latam @Stryker

Newbury, GB
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Jul 2022 — Present

Director, Regulatory Affairs, Emea & Latam @Stryker

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Newbury, GB

Global Fortune 500 leader in medical technologies offering innovative products and services in MedSurg, Neurotechnology and Orthopaedics to help improve patient and healthcare outcomes. • Define and execute international regulatory strategies, approval pathways and advocacy initiatives to achieve regulatory compliance and successful market access across Europe, Middle East, Africa and Latin America (50+ countries). • Regional regulatory head, centre of excellence leader and global project owner for international harmonisation initiatives. • Line management of an international regulatory team comprised of 15 headcounts, driving employee engagement, coaching and mentoring and career development programs.

EDUCATION

2012 — 2014

Cranfield University

Executive MSc Medical Technology Regulatory Affairs

2006 — 2010

Loughborough University

BSc (Hons) International Business

2019 — 2019

Harvard University

Americas and EMEA Executive Leadership Program

SKILLS

Medical DevicesCapaRegulatory RequirementsRegulatory AffairsOrthopedicHealthcarePost Market SurveillanceCross-Functional Team LeadershipJoint RegistriesMedical Device DirectiveCe MarkingVigilanceCorrective and Preventive Action (Capa)Quality AssuranceLeadershipQuality ManagementQuality SystemClinical TrialsSopOrthopedicsIso 9001:2008

ABOUT DANIEL RANA

A senior medical device regulatory leader with the ability to combine knowledge of technical and commercial practices to ensure compliance and successful market access in both mature and emerging markets. Acquired extensive expertise in both pre-market and post-market regulatory affairs including international product registrations, CE marking, mergers and acquisitions and working with direct and indirect distribution channels. Experienced Lead QMS Auditor with a reputation for driving continuous improvement throughout all business functions and disciplines.Proven ability in building and maintaining successful long-term working relationships with international regulatory agencies, Notified Bodies and medical technology industry associations. Proven and measurable track record in leading and developing international RAQA teams, managing global projects and consistently exceeding Corporate and regional metrics.

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Daniel Rana — Director, Regulatory Affairs, Emea & Latam at Stryker in Newbury, GB | Unifers