Nancy Boodhun - Chief Clinical Operations & Strategy Officer | Eclevar MedTech
Nancy Boodhun - Chief Clinical Operations & Strategy Officer
Chief Clinical Operations & Strategy Officer

Nancy Boodhun

Medical Device Clinical Affairs Expert | Global Clinical Strategy Leader

Johnson & Johnson
Ex DePuy Synthes (J&J), NAMSA, RQM+, Abbott Diabetes Care
25+ years experience
Class III Expert
Orthopaedics & IVD

Accomplished clinical affairs leader with over 25 years of experience in medical device clinical strategy, regulatory compliance, and global clinical operations. Proven track record in orthopaedics, IVD, and Class III devices, from protocol development to publication. Expert in PMCF studies, clinical investigations, and evidence generation strategies for EU MDR and global market access.

Executive Snapshot

Clinical strategy, evidence generation, and regulatory excellence

A strategic leader trusted to design, execute, and deliver global clinical evidence programs that drive regulatory approvals and commercial success for medical device manufacturers

CER

Clinical Evidence Strategy

End-to-end development and execution of clinical evidence strategies for regulatory submissions, market access, and business goals across EU MDR, FDA, and global markets

OPS

Global Clinical Operations

Oversight of clinical investigations and PMCF studies from protocol development to publication, including site selection, monitoring, budget management, and reporting

REG

Regulatory & Technical Documentation

Clinical evaluation, technical documentation, and regulatory clearance support for new product developments across orthopaedics, IVD, and high-risk medical devices

Therapeutic expertise
Orthopaedics, hip, trauma, extremities, IVD

Study types
PMCF, Clinical Investigations, Investigator Initiated Studies

Leadership
Commercial development, global accounts, consulting services

Career Highlights

25+ years shaping medical device clinical excellence

Chief Clinical Operations & Strategy Officer

CURRENT

Eclevar MedTech

Leading clinical operations and strategic initiatives for medical device manufacturers, driving evidence generation strategies and regulatory compliance across EU MDR and global markets.

Managing Director

Proceed Clinical Ltd · Sept 2024 - Present

Specialist consultant to medtech manufacturers, developing and executing clinical evidence strategies to achieve regulatory and business goals.

Head of European Business Development

RQM+ · Apr 2024 - Sept 2024

Led European business development initiatives for clinical and regulatory services.

Sr Global Clinical Strategy Director

NAMSA · Aug 2021 - Nov 2023 (2 yrs 4 mos)

Led commercial development and sales of clinical and consulting services for new and existing global accounts. Previously served as Senior Clinical and Consulting Specialist (Jul 2017 - Aug 2021).

6+ years at NAMSA
Johnson & Johnson 12 YEARS

Staff Clinical Research Scientist

DePuy Synthes Companies (Johnson & Johnson) · Jul 2014 - Jul 2017

Development, management and delivery of global clinical strategies for orthopaedic implants. Oversight of clinical operations for Clinical Investigations and PMCF studies. Clinical representative for new product developments.

Clinical Project Leader

DePuy Orthopaedics · Aug 2005 - Jul 2014 (9 years)

End-to-end management of post market and regulatory Class III orthopaedic device studies (hip, trauma, extremities). Management of International Joint Reconstruction Investigator Initiated Study portfolio.

Senior CRA

Abbott Diabetes Care · 2001 - 2005 (4 years)

End-to-end management of post market IVD studies, including protocol development, monitoring, data analysis and reports, publication. Review and update of clinical quality system procedures.

Biomedical Scientist

NHS Trust · 1998 - 2001

Haematology and Blood Transfusion specialist at Addenbrookes Hospital and Great Ormond Street Hospital for Children. Experience in haematological malignancy diagnosis and RFLP analysis for bone marrow transplantation.

Reforming Clinical Evaluation of Medical Devices in Europe