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.
A strategic leader trusted to design, execute, and deliver global clinical evidence programs that drive regulatory approvals and commercial success for medical device manufacturers
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
Oversight of clinical investigations and PMCF studies from protocol development to publication, including site selection, monitoring, budget management, and reporting
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
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.
Proceed Clinical Ltd · Sept 2024 - Present
Specialist consultant to medtech manufacturers, developing and executing clinical evidence strategies to achieve regulatory and business goals.
RQM+ · Apr 2024 - Sept 2024
Led European business development initiatives for clinical and regulatory services.
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).
12 YEARS
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.
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.
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.
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.