Professional Summary
Professional Overview
Jack Kromenhoek is an experienced Regulatory Affairs professional with a strong track record of success in the medical device industry. As the Director of Regulatory Affairs at Abbott, he leverages his extensive expertise to navigate complex regulatory environments and ensure compliance while driving strategic initiatives that support business growth.
Experience Summary
Current Role
As the Director of Regulatory Affairs at Abbott, Jack is responsible for leading a team of regulatory specialists in managing the company's global regulatory affairs strategy. He oversees the submission and approval of regulatory filings, collaborates with cross-functional stakeholders, and implements robust quality systems to maintain regulatory compliance. Under his leadership, the team has successfully navigated the regulatory approval process for several of Abbott's innovative medical devices, contributing to the company's market expansion and revenue growth.
Career Progression
Prior to his current role, Jack held progressively senior positions in Regulatory Affairs at leading medical device companies, including Smiths Medical and St. Jude Medical. He has accumulated over 15 years of industry experience, honing his skills in navigating global regulatory landscapes, managing complex projects, and driving continuous improvement initiatives. Throughout his career, Jack has demonstrated a strong ability to adapt to changing regulatory requirements, effectively communicate with key stakeholders, and deliver measurable results that have positively impacted his employers' business objectives.
Academic Background
Jack holds a Bachelor of Science degree in Mechanical Engineering from the University of Minnesota, where he graduated with honors. His technical expertise and academic achievements have been instrumental in his ability to understand complex regulatory frameworks and translate them into practical solutions for his organizations.
Areas of Expertise
- Regulatory strategy and compliance
- Global regulatory affairs management
- Quality system implementation and maintenance
- Medical device development and life cycle management
- Cross-functional collaboration and stakeholder engagement
- Project management and continuous improvement
Professional Impact
During his tenure at Abbott, Jack has played a pivotal role in securing regulatory approvals for several of the company's innovative medical devices, enabling their successful market introduction and contributing to the organization's growth. He has also led the implementation of robust quality systems and process improvements, enhancing the efficiency and reliability of the company's regulatory operations.
Conclusion
With his extensive expertise in Regulatory Affairs, proven track record of success, and deep industry knowledge, Jack Kromenhoek is well-positioned to continue driving strategic initiatives that support the growth and competitiveness of Abbott's medical device portfolio. His ability to navigate complex regulatory environments, collaborate with cross-functional teams, and deliver measurable results make him a valuable asset to the organization.