Frank Pokrop is a seasoned professional certified in regulatory affairs and quality assurance, with a career spanning over 15 years of driving excellence in the medical device and healthcare industries. His expertise encompasses medical devices (Class I through Class III), software/SaMD, capital equipment, and injectable drugs, with a proven track record of delivering impactful results in regulatory strategy, quality systems management, and corporate leadership.
Frank’s career journey includes pivotal roles such as Manager, Director, and Senior Director, during which he successfully liaised with the FDA across multiple product lines, as well as non-U.S. healthcare agencies and professional societies. He has served as the EU Person Responsible for Regulatory Compliance (PRRC), navigating complex global regulatory landscapes and overseeing international product approvals. His ability to lead teams has been evident in his management of up to 10 direct and 60 indirect reports, fostering the development of regulatory professionals and ensuring alignment across five global R&D locations.
A strategic thinker and collaborative leader, Frank has delivered measurable successes, including driving annual cost reductions exceeding $3 million USD. He has been the regulatory contact for three corporate boards, where he spearheaded planning and cost management strategies for new regulations. His leadership extends to authoring and guiding teams through successful new product approvals on a global scale, including the authoring of 20 on-time 510(k) submissions.
Frank’s accomplishments reflect his meticulous approach to compliance and inspection readiness. He directed a global compliance program across 48 worldwide sites, implementing robust metrics, scheduling systems, and strategies for resolving audit issues. His expertise in regulatory compliance is further demonstrated by his leadership in company-wide training on new regulations, global recall management, and supplier audit preparation.
Certified as a Regulatory Affairs Certified (RAC), Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), Certified Software Quality Engineer (CSQE), and Certified Pharmaceutical GMP Professional (CPGP), Frank possesses a comprehensive skill set tailored to the needs of the highly regulated medical and pharmaceutical industries. His academic foundation includes a Bachelor of Science in Biology from the University of Wisconsin and a Certificate in Executive Management from UCLA, underscoring his commitment to lifelong learning and professional development.
Frank’s personal attributes further distinguish him as an executive leader. Known for his natural collaborative spirit, constructive communication, and deadline-driven focus, he builds trust and delivers results in dynamic and high-pressure environments. His career history includes tenure at industry-leading companies such as Abbott, BD, CareFusion, and QuidelOrtho, where he has consistently exceeded expectations and set benchmarks for excellence.
Frank Pokrop is now seeking a senior position in regulatory affairs or quality assurance, where his extensive experience, strategic mindset, and leadership acumen can contribute to the success of a forward-thinking organization.
Character
Frank Pokrop is a natural collaborator known for his constructive approach, confidentiality, and unwavering commitment to meeting deadlines while fostering trust in all professional interactions.
Knowledge
With certifications in regulatory affairs and quality assurance, coupled with over 15 years of expertise across medical devices, software, and injectable drugs, Frank brings a deep understanding of compliance, product approvals, and global regulatory landscapes.
Strategic
Frank has demonstrated a consistent ability to lead cost-saving initiatives, manage complex global compliance programs, and develop strategies that align with evolving regulations to ensure organizational success.
Communication
An active and transparent communicator, Frank excels in bridging gaps between regulatory bodies, corporate boards, and cross-functional teams to drive clarity, collaboration, and alignment in achieving business objectives.
