The Experts Behind Your Next Medical Technology Milestone

Jason Gromek

President & CEO

Jason Gromek is an experienced executive and quality consultant with over 20 years of leadership in medical device design, regulatory compliance, and quality systems. With a deep foundation in product development, commercialization, and operational strategy, Jason has built a career helping medical device, diagnostic, and combination product companies bring innovative technologies to market efficiently and compliantly.

Jason has been with Medicept for over 10 years, where he has held progressive leadership roles. He has been a key contributor to the development and implementation of 21 CFR 820 and ISO 13485-compliant Quality Management Systems, leading initiatives across product development lifecycle management and both U.S. and EU regulatory guidance. His expertise spans FDA Warning Letter and 483 remediation, Design Controls (21 CFR 820.30), CAPA systems, Software Validation (21 CFR 11), Risk Management (ISO 14971), Electrical Safety (IEC 60601), Software Development (IEC 62304), and PLM systems like Arena.

Before becoming President and CEO of Medicept, Jason served as Executive Vice President of Sales and Operations, where he led the Sales, Quality, Regulatory, and Clinical teams. In his current role, he is responsible for setting and executing company-wide strategic direction, cultivating long-term client relationships, and promoting a collaborative, performance-driven culture.

Prior to joining Medicept, Jason was the Founder and President of BioDevice Design, LLC, a medical device development firm and founding member of America Makes—the National Additive Manufacturing Innovation Institute. He also held leadership roles at Meditech Spine, where he spearheaded regulatory clearance efforts for Hydroxyapatite-PEEK technology, making Meditech only the second company in the world to receive such clearance. In addition, he worked as a medical device design consultant at O’Savage Biomechanics and holds multiple patents in the field of spinal implants.

Jason is a member of the American Society for Quality (ASQ) and is a Certified Biomedical Auditor and Certified Quality Auditor. He remains passionate about building strong teams, fostering strategic partnerships, and ensuring companies have the regulatory, quality, and clinical foundations necessary to succeed in today’s dynamic healthcare landscape.

Marieke Kirkman

Managing Director

Marieke Kirkman is a seasoned commercial leader with more than 20 years of success in building strong client partnerships and driving growth across global markets. With a career grounded in strategic thinking, and a genuine commitment to client success, she brings a wealth of experience spanning the quality and regulatory, energy, and technology sectors. Her expertise includes commercial strategy, business development, building partnerships with clients complemented by broad experience leading multidisciplinary teams and scaling operations across complex, highly regulated industries.

As Managing Director at Medicept, Marieke is responsible for the strategic direction and operational execution of all commercial functions, with oversight across revenue growth, client relationships, and commercial operations. She brings a client-centered approach to building and scaling teams, ensuring the delivery of exceptional service while driving sustainable business growth.

Before joining Medicept, Marieke served as Chief Commercial Officer at ZigZagQA, a quality and regulatory solutions firm, where she led the commercial organization and drove growth-centered strategy. Prior to that, she held a leadership position at ADAMAS Consulting, most recently as Vice President of Business Development, where she oversaw their global client management portfolio. Earlier in her career, she held various global operational roles in the energy sector and technology positions at Occidental Petroleum and Tatweer Petroleum.

Marieke attended Colorado School of Mines.

Carolyn Russell

VP, Technical Services, QARA

Carolyn Russell is a seasoned leader in Quality Assurance and Regulatory Affairs with over 25 years of proven success in developing and implementing quality management systems for global organizations. With a career dedicated to enhancing compliance, streamlining processes, and mentoring teams, she brings a wealth of experience. Although her focused area of expertise includes Quality and Compliance Management, QMS harmonization, remediation efforts, risk management, supplier management, CAPA, training, and document and change management, she has broad experience and in-depth knowledge of FDA and international requirements pertaining to product development, risk management, and post-market activities. In addition, she has assisted clients with Adverse Event reporting, annual reporting, UDI and FDA facility and device registrations.

As VP Technical Services – QARA, Carolyn is responsible for strategic direction and operational execution of the Quality Assurance (QA) and Regulatory Affairs (RA) services, including leading the team of QA/RA professionals while ensuring the delivery of high-quality, compliant, and efficient consulting services. In addition, she serves as a subject matter expert, providing strategic guidance to clients and internal teams on complex regulatory and quality challenges. Deep understanding of global medical device regulations, quality management systems, and successfully navigating the complexities of the medical device industry. She performs internal audits, supplier audits, assist clients with FDA investigations and ISO assessments, and deliver customized client training and education programs.

Before joining Medicept, she worked as a compliance leader in the medical device and manufacturing industry (SaMD, radiology, aesthetic lasers, and cardiac devices). This includes serving as Director of Quality, Senior Manager of Quality and Compliance, and Senior Quality Manager, including designation as Management Representative and US Agent for foreign business units.

Carolyn holds a B.S. degree in Business Studies, Industrial Organizational Psychology from Southern New Hampshire University. She’s a member of American Society for Quality (ASQ) and Regulatory Affairs Professional Society (RAPS) and is a Certified Quality Auditor through ASQ and holds several lead auditor certifications and a Regulatory Affairs Certificate: Medical Devices through RAPS.

Celeste Grant

VP, Global Clinical & CRO Services

Celeste Grant is a highly accomplished professional with a diverse background in clinical operations, nursing, and leadership. She has over 25 years of experience in oncology, neurology, and cardiology within medical devices including combination device and pharmaceutical products. Celeste has a proven record of success in leading and motivating teams, driving operational excellence, and achieving strategic goals. She is a highly effective communicator and collaborator which enables her to build strong relationships with stakeholders at all levels. Celeste is a passionate and results-oriented leader who is committed to making a positive impact on the lives of others.

As VP, Clinical and CRO Services at Medicept, Celeste is responsible for providing strategic leadership and oversight of clinical research activities, performance oversight, and operational delivery. She collaborates with cross-functional teams, driving strategic partnerships and optimizing operations to enhance organizational objectives.

Before joining Medicept, Celeste served as Sr. Director, Global Clinical Operations at Novocure GmbH where she spearheaded the expansion of new indications into Asia Pacific and Latin America. Celeste also championed the establishment and leadership of the Japan Clinical Operations, launching clinical studies in Japan. Prior to this, she held leadership positions at Atlantic Research Group and Covance. Earlier in her career she served as a Registered Nurse in Labor & Delivery, Nursery, OR and PACU.

Celeste holds an Associate’s Degree in Nursing from Marymount University, a Bachelor of Science degree in Management and Organizational Development from Mount Olive College and in progress of a Master of Science in Nursing Leadership and Administration.

Lisa Wagner

VP, Human Resources

Lisa is an accomplished Human Resources professional holding a Senior Professional Human Resources (SPHR) certification with over 25 years of experience leading human resources operations and organizational planning. Lisa is well-versed in employment law, performance appraisals, salary structure, and benefits program management. She is a seasoned expert at protecting company interests and building a successful company culture, promoting employee retention and performance.

As the Vice President of Human Resources at Medicept, Lisa is an integral part of the executive management team, driving the development of creative strategies to support rapid business growth with a focus on the mission, vision, and values of Medicept.

Before joining Medicept in 2021, Lisa was the Director of Human Resources for Canyon Ranch in Lenox, Massachusetts, and Starwood Hotels & Resorts Worldwide, Inc. With nearly 30 years of hospitality experience, Lisa understands the importance of communication and employee engagement.

Attending both Mount Ida College and Cornell School of Industrial & Labor Relations, Lisa has a passion for Human Resources and continuous learning. She holds both a PHR & SPHR certification and a certification in Human Resources Studies through Cornell. Lisa is a member of many human resources organizations and has previously held a seat on the Board of Directors for the Hospitality Human Resources Association of Arizona and the Berkshire Country Regional Employment Board.

Dave Rothkopf

Founder

F. David Rothkopf has 35 years of professional strategic experience in the development and regulatory control of medical devices. He is the Founder and on the Board of Directors of Medicept Inc., established in 1996, offering innovative, trusted, and cost-effective Quality, Regulatory, and Clinical solutions to the medical device and invitro diagnostic industries. His expertise includes technical and hands-on knowledge in a variety of regulatory, compliance management, and quality process. He has performed over 400 ISO 13485 and FDA-style audits in the past 20 years. David has submitted over sixty-five 510ks and PMAs. He has trained many medical companies and the FDA on the intricacies of Design Control, CAPA, Software Validation, Risk Management, and Hazard Mitigation throughout a product life cycle.

David is an adjunct professor at MIT advising Doctoral students in Regulatory Affairs, a mentor for MassChallenge Accelerator, MIT Idea2 program, NIH’s NHLBI Catalyze Program, HHS’s ARPA-H Program, and now advises undergraduates at the University of Texas, Dallas and Worcester Polytechnic Institute. He is also, a shareholder advisor for four device companies and a partner in two orthopedic device companies. Before joining Medicept, he was the Chief of Operations and co-Founder of Zmed and Chief of Operations and co-Founder of Mrad and was instrumental in their sale. He was the Director of Quality at Uromed and a Project Leader at Johnson and Johnson Professional.

David holds a B.S and M.S degree in Mechanical Engineering from Worcester Polytechnic Institute and an MBA from Boston University. He is a member of RAPS, ASQ, ASQ Biomedical, and ASME. He is a Board Member and Treasurer for a not-for-profit special needs school.