Tara Turney
Senior Director, Regulatory Affairs @BD
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WORK HISTORY
Senior Director, Regulatory Affairs @BD
US
Continuing to lead and grow one of best regulatory teams in the industry, the Advanced Repair and Reconstruction RA team in BD Surgery.*• Platform regulatory lead for Advanced Repair and Reconstruction covering absorbable and synthetic surgical meshes and fixation devices achieving $758M in revenue in FY24• Leader of a 17-person team including five people managers and 12 specialists spanning work across Plastic & Reconstructive Surgery and Hernia clinical spaces
EDUCATION
Northeastern University
M.S., Leadership
Northland College
BS, Biology
SKILLS
ABOUT TARA TURNEY
Transformational, strategic, and dynamic regulatory team leader with over 20 years of medical device experience, possessing a unique mix of start up agility with large company rigor. Substantial track record of driving cultural change in organizations and embodying servant leadership. Strong focus on associate growth, coaching and development, and building and retaining high functioning regulatory teams. A HAL-C trained leader focused on creating trusted stakeholder relationships and realizing the collective potential of people, purpose and performance to make a difference in global healthcare.Expansive global regulatory and quality expertise, including working and living in Asia as a consultant specializing in small to mid-size device firms looking to break into the US market. Frequently brought in to facilitate submission clearance/approvals for organizations with previously unsuccessful submissions or overwhelming requests from regulatory agencies. BSI-certified lead auditor with extensive auditing experience in internal and supplier quality systems as well as due diligence auditing. Leveraged local presence as a quality auditor and due diligence lead for Asia-based supply chains. Primary experience in the cardiovascular, diabetes, surgical mesh, and ophthalmic markets spanning surgical device systems, drug delivery devices, consumer IVDs and combination products, digital health apps, and software as a medical device.Regulatory skill sets and experience include: Global regulatory strategy development across all classes of medical devices, new product development and global change management, FDA Warning Letter/Consent Decrees and third-party audit remediation, recall coordination, due diligence and post-acquisition regulatory and quality system integration, quality system improvement projects and QMS implementation.
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