Patrick Mccullagh Email & Phone Number

West Chester, PA, US

Raynham, MA, US

Oversee the strategic regulatory direction for pipeline development and global launch excellence for the $4 billion DePuy Synthes Joint Reconstruction, Powertools and Digital Solutions platform.Lead a team of RA professionals in USA and EU to support the timely introduction of new products and technologies globally through the regulatory processes.

Raynham, MA, US

Oversaw the strategic regulatory direction for pipeline development and global launch excellence for the $3 billion DePuy Synthes Trauma, CMF and Biomaterials platform.Led a team of RA professionals in USA and EU to support the timely introduction of new products and technologies globally through the regulatory processes.

Warsaw, Indiana, US

• Led a team developing and implementing quality systems, compliance, and regulatory strategies for the $400M Zimmer Trauma business.
• Enhanced time to market and engaged entrepreneurial spirit within Zimmer Trauma increasing FDA regulatory clearances to double digits annually.
• Recommended and implemented global elabeling program improving corporate green image and mitigating risk.
• Defended regulatory and third body inspections/audits of quality system, e.g. U.S. Food & Drug Administration (FDA) inspections and European Union (EU) Notified Body audits, maintaining and enhancing market standing.

Leesburg, Virginia, US

• Developed and implemented the global regulatory, quality systems, compliance, and clinical research strategies.
• Enhanced revenue recognition with 510(k) FDA spinal system clearances annually in double digits.
• Successfully defended FDA, ANVISA (Brazil) and Notified Body inspections/audits.

Lund, SE

• Developed and directed the global regulatory, clinical, medical affairs, science and publication strategies for the market introduction and continuing support of new technologies.
• Gained approval of novel Class 3 technologies in Europe and Canada, namely Cerament™ Spine Support and Cerament™ Bone Void Filler.
• Led the regulatory strategy for the Class 3 Cerament™ Spine Support Technology in the U.S., including arranging a pre-meeting with the FDA on the IDE submission and the preparation of the roadmap for the PMA.

Mentor, OH, US

• Developed and directed the global regulatory, compliance and quality strategies to reduce the time-to-market for key product introductions worldwide and to deliver product quality with highest standards.
• Led the submission and clearance of over 30 510(k) medical devices including sterilization systems, biological and chemical indicators, and LED operating theatre surgical lights.
• Defended facility quality management systems to regulatory body, notified body and customer audits, including approximately 12 to 15 FDA inspections annually.

Responsible for developing and implementing regulatory, marketing and sales strategies for the introduction of new Orthobiological Products in the U.K., Ireland and Northern Europe. Contributed to the global strategy for regulatory, clinical and marketing. Worked with a unique combination of Notified Bodies, Competent Device Authorities and Competent Drug.

Responsibilities included leadership of regulatory, quality, clinical, packaging and labelling teams. As a Management Board member, supported the planning and implementation of acquisitions and led the international DePuy-DuPont joint venture for novel polymers with full Profit & Loss responsibility. A key requirement was the close liaison with the.

Ph.D, Bio-Medical Engineering

M.Sc, Tribology

B.Sc (Hons.), Mechanical Engineering