Sr. Principal Regulatory Affairs Specialist

• Jul 2022 - Present

• Secured CE mark certification for a cutting-edge CT contrast injection system, enhancing diagnostic imaging capabilities • Demonstrated strong leadership as regulatory lead on project core teams and change control board for efficient software development • Reviewed and approved marketing communication and training materials • Submitted a license amendment to Health Canada • Exhibited strong partnerships with sustaining engineering teams and mentored regulatory team members on projects for consumable devices, injector hardware, electronics, software, and labeling • Reviewed verification and validation (V&V) technical documentation sections and GSPRs for two EU MDR submissions • Conducted comprehensive review of PMS plans, PSUR, CEP and CER documentation • Served as trusted advisor and regulatory subject matter expert for clinical evidence and clinical trials requirements • Streamlined and revised the work instruction for global regulatory impact assessments

Manager, Regulatory Affairs

• May 2021 - Jul 2022

• Authored client deliverables including regulatory strategy, submissions (PMA/S, Q-Submissions, IDE, EU MDR Technical Documentation, and Canada Class III premarket medical device license), and global change assessments for Johnson & Johnson Surgical Vision• Performed regulatory project lead responsibilities for new product development of investigational intraocular lenses (IOLs) for US and EU clinical trials; created and delivered presentations for internal gate reviews and FDA meetings• Reviewed change orders, submissions and product labeling for ophthalmic devices• Evaluated new regulation in China for self-testing of medical devices• Oversaw regulatory team member client deliverables and provided consulting to global project teams• Led, coached, and developed direct reports based remotely throughout the US• Liaised with clients and Network Partners for business development opportunities• Developed training content and provided instruction to the Apprentice Leadership Program for topics including US and EU Class III devices, De Novo, Japan and Canada.• Engaged with internal and external senior leaders and experts on the Regulatory Advisory Board

Principal Regulatory Affairs Consultant

• Mar 2021 - May 2021

• Provided clients with medical device regulatory experience and expertise to help bring life-saving products to market.• Provided consulting for US, Canada and EU submission activities for intraocular lenses and ophthalmic viscoelastic devices.

Principal Regulatory Affairs Specialist

• Aug 2018 - Feb 2021

• Represented regulatory function for spine business franchise for device implants and instruments • Managed projects for sports medicine including human tissue allografts, HCT/P and biologics • Led regulatory activities for COGS reduction projects that saved the company $2M • Prepared for and participated in BSI MDD recertification audit and closed out all audit questions • Initiated process improvements for audit and change assessment procedures • Interfaced with consultants, international distributors, regulators, Notified Body, OEM partners • Lead product submissions for China and Australia • Reviewed and approved advertising and promotion materials on promotional review committee

Principal Consultant

• Oct 2017 - Aug 2018

Principal Regulatory Affairs Specialist

• Aug 2016 - Sep 2017

•Integrated BSC regulatory systems and processes into American Medical Systems (AMS) acquisition•Managed multiple work streams as regulatory lead for quality system remediation, design and process changes, validations, and submissions to resolve AMS’s FDA Warning Letter items•Designed and presented training to engineering and regulatory departments in MN and CA•Supported Men’s Health product lines for Implantable Penile Prostheses (IPP’s) and Artificial Urinary Sphincter

Principal Regulatory Affairs Specialist

• Sep 2014 - Aug 2016

•Managed US, EU, Japan, and international (including emerging markets) submissions: IDE, PMA, supplements (panel track, real-time review, numerous 30-day notices,), annual and periodic reports, 510(k), Design Dossiers, Technical Files, Chiken Todoke, Shonin, and international dossiers•Specialized in combination drug/devices (drug-eluting stents), devices (cardiovascular and peripheral vascular guide wires, catheters, balloons, and capital equipment) •Interacted directly with FDA, Notified Body, and PMDA•Developed and executed global regulatory strategy for new products•Designed and evaluated clinical study protocols and reports, case report forms, and budgets for pivotal and post-approval studies•Evaluated manufacturing and process changes for cardiovascular devices with $1B in sales•Integrated an acquisition company•Completed 4-month international assignment in Tokyo, Japan•Demonstrated excellent project management, submission writing, and negotiation skills

Sr. Regulatory Affairs Specialist

• Feb 2010 - Sep 2014

Regulatory Affairs Specialist II

• Oct 2006 - Feb 2010

Regulatory Affairs Coordinator

• Jun 2004 - Oct 2006

•Managed and compiled annual report submissions to FDA for 90 approved drug applications•Reviewed and approved change control documents pertaining to NDA/ANDA submissions•Collaborated cross-functionally with project teams, contract manufacturers, and consultants to obtain required documentation for regulatory submissions•Developed strategy to ensure compliance with FDA regulations and guidance documents

Analytical R&D Intern

• Jan 2004 - Jun 2004

•Performed method development and validation, technical writing, and project reporting•Managed cleaning and process validation testing for numerous pharmaceuticals•Complied with GLP and cGMP regulations and SOPs

Research Associate

• Aug 2000 - Dec 2003

Processed animal and human tissues for pre-clinical and clinical studies for pharmaceutical company, hospital, and university research projects Imaged and evaluated specimens with light microscopy, laser microscopy, SEM, and TEM Processed animal and human tissues for pre-clinical and clinical studies for pharmaceutical company, hospital, and university research projects Imaged and evaluated specimens with light microscopy, laser microscopy, SEM, and TEM