Summary
Overview
Work History
Education
Skills
Affiliations
Timeline
Generic
Nicole Bongers

Nicole Bongers

Missoula,MT

Summary

Accomplished executive with 25 years of experience leading clinical, regulatory, and quality functions and teams in the medical device industry. I have successfully managed clinical development programs, secured timely global regulatory approvals, and established robust quality management systems compliant with applicable standards. My integrated approach ensures the delivery of safe, effective, and compliant medical devices, driving operational excellence and innovation across organizations.

Overview

24
24
years of professional experience

Work History

TEAM MANAGER, MEDTECH BUSINESS CONSULTING

Veeva Systems
12.2021 - Current
  • Guide major medical device and diagnostic companies in designing and implementing digital transformation strategies to enhance their business operating models.
  • Guide and support organizations in areas including outsourcing and resourcing models, portfolio prioritization, organizational design, governance frameworks, and funding strategies to drive operational excellence and strategic growth.
  • Drive the creation and implementation of advanced data and operational processes to harmonize workflows, enhance efficiencies, and optimize performance – reducing timelines, effort, and costs while ensuring improved compliance with global medical device and diagnostic companies.
  • Develop and build a net new revenue-generating business unit within a large global company.
  • Frame Veeva’s Heath Equity and diversity in clinical trials initiative by working collaboratively with various organizations and government agencies to drive impactful Health Equity efforts.
  • Create innovative strategic business solutions and establish a strong presence in the medical device industry to displace traditional consulting firms.
  • Manage the internal operating budget while strategically expanding and cultivating a dynamic team of consultants to drive organizational success and efficiency.
  • Spearhead high-impact communication and strategic engagements with executive leadership teams in global medical device and diagnostic companies, fostering strong partnerships.
  • Develop process for data driven decisions including protocol and endpoint development, patient segmentation and recruitment, KOL identification, and investigational sites.

VICE PRESIDENT OF CLINICAL AND REGULATORY AFFAIRS

Cardiomech
04.2019 - 12.2022
  • Led pre-clinical, clinical, regulatory, and medical affairs for a novel mitral valve repair technology, ensuring a seamless transition from concept to human trials through strategic planning and execution.
  • Oversaw the development and submission of regulatory documents, including interactions with the FDA, managing submission writing, communications, and advocacy to facilitate a clear regulatory pathway.
  • Authored and directed regulatory submissions and clinical study documents, ensuring alignment with FDA requirements and industry standards to expedite approval processes.
  • Executed the First-in-Human clinical trial, building the necessary clinical infrastructure to support study oversight, patient safety, and data integrity for groundbreaking structural heart technology.
  • Established and fostered relationships with key stakeholders in structural heart medicine, engaging with physicians, researchers, and regulatory bodies to advance innovation and clinical adoption.
  • Led strategic due diligence and fundraising efforts, identifying investment opportunities, managing partnerships, and securing funding to drive product development and commercialization.
  • Developed and maintained a compliant quality management system, ensuring ongoing regulatory compliance and adherence to evolving industry standards for safety and efficacy.

DIRECTOR OF CLINICAL AFFAIRS

Neuspera Medical
05.2018 - 04.2019
  • Led strategic clinical and regulatory pathways for multiple indications of platform neuromodulation technology, shaping the development and approval process to optimize patient outcomes and market access.
  • Collaborated with cross-functional departments, including Marketing, Regulatory, Reimbursement, R&D, and Operations, ensuring product clinical readiness and seamless integration into commercialization strategies.
  • Directed communications and interactions with regulatory bodies, managing submissions, advocacy, and negotiations to align with evolving regulatory landscapes and expedite approvals.
  • Led customer engagement initiatives, facilitating focus group sessions with patients and physicians, organizing Scientific Advisory Boards, and gathering key insights to refine product development and commercialization efforts.
  • Developed clinical claims and clinical evidence, supporting commercial marketing and labeling claims while ensuring alignment with rigorous study design and execution strategies.
  • Authored and managed regulatory submissions and clinical study documents, ensuring compliance with industry standards and regulatory expectations to drive successful approvals and clinical adoption.

PRINCIPAL PRODUCT DEVELOPMENT STRATEGIST

NAMSA
01.2017 - 05.2018
  • Led and developed Go-to-Market strategy plans for medical device companies and individual entrepreneurs, ensuring seamless integration of clinical, regulatory, and commercial considerations to drive market success.
  • Directed multi-disciplinary teams to align regulatory, clinical, reimbursement, marketing, scientific communications, and commercialization strategies throughout the product development lifecycle, ensuring cohesive execution.
  • Designed strategic pathways for new technology adoption, expertly navigating the regulatory process, including first-in-human studies, pre-market IDEs, and post-market clinical studies across U.S. and international markets.
  • Provided due diligence support to medical device investors, conducting comprehensive assessments and delivering strategic recommendations to optimize investment decisions.
  • Led customer engagement activities, facilitating focus group sessions with patients and physicians to gather key insights that refine product development and commercialization strategies.
  • Advised on global regulatory frameworks, providing strategic guidance on international regulatory bodies to streamline market entry and authored regulatory submissions, ensuring compliance with evolving regulatory standards and facilitating timely responses to inquiries.
  • Developed clinical claims and supporting evidence to align commercial marketing, labeling, and regulatory approval processes with robust clinical study designs.
  • Created and executed KOL strategies, identifying, recruiting, and retaining influential experts while mapping their journey from awareness to advocacy.
  • Facilitated FDA meetings, providing strategic direction to clients on FDA communications, submissions, and regulatory pathways and led strategy for FDA Advisory Panels.
  • Engaged in industry advisory committees, spearheading collaborations between government agencies to address key medical device trial topics and regulatory considerations.

MANAGER, CLINICAL RESEARCH SERVICES

NAMSA
01.2015 - 01.2017
  • Directed clinical operations, ensuring alignment with business objectives through strategic planning, coordination, and execution.
  • Managed financial performance, overseeing budgeting, forecasting, expenditures, and corrective actions to meet departmental goals and drove revenue growth, identifying new clientele, preparing proposals, and leading bid defenses to establish strategic partnerships.
  • Led policy development and process improvements to enhance efficiency and compliance and improved quality while reducing costs.
  • Supported regulatory submissions, guiding IDEs, 510(k) applications, De Novo submissions, and Pre-market approvals.
  • Provided FDA engagement support, advising clients on regulatory communications and submission strategies.
  • Conducted training for FDA reviewers, educating regulators on clinical research and trial processes.
  • Led internal and external audits, supporting BIMO inspections and ensuring compliance.
  • Fostered staff development, coaching employees, conducting performance reviews, and overseeing professional growth for direct reports and contractors.
  • Led talent acquisition and retention, recruiting, training, and mentoring clinical research professionals to ensure a qualified workforce.

SR. MEDICAL RESEARCH MANAGER

NAMSA
07.2010 - 01.2015
  • Developed and executed clinical strategies from first-in-human trials through pivotal and post-market studies.
  • Designed essential study documents, including protocols, informed consents, investigator brochures, and case report forms.
  • Managed clinical studies and cross-functional teams, ensuring coordination across clinical, regulatory, and commercial functions.
  • Led study start-up activities, overseeing site selection, contract negotiations, IRB/EC submissions, and essential document collection.
  • Trained study teams and site personnel, ensuring compliance with study protocols and regulatory requirements.
  • Directed clinical committees and advisory boards, managing member selection and contractual agreements.
  • Authored study reports and supported publication efforts, contributing to abstracts and manuscripts.
  • Managed budgets, contracts, and resource allocation, optimizing efficiency for client projects.
  • Developed new business opportunities, securing clients through proposals and strategic contract execution.
  • Established and implemented SOPs, standardizing clinical study conduct for teams and investigational sites.
  • Supported audit preparation, ensuring compliance with internal and regulatory standards.

CLINICAL RESEARCH/STUDY MANAGER

ev3 Endovascular, Inc.
07.2007 - 07.2010
  • Managed all activities associated with the design, execution, and reporting of two post market clinical studies including investigator, site and contract research organization selection.
  • Collaborated with business development and marketing to identify clinical trends relevant to company’s strategic goals.
  • Established and maintained relationships with physician investigators, steering committee members, and site research coordinators.
  • Managed and oversaw core laboratories including development of site and study protocols, data review processes and analyses, and quality control.
  • Managed clinical events committees and data safety monitoring boards.
  • Oversaw CRO to ensure deliverables were met within allocated budget.
  • Developed study documents including protocol, CRFs, monitoring plan, reimbursement guide, data management plan, statistical analysis plan, data safety monitoring board charter, and publication plan.
  • Oversaw clinical sites with responsibilities including negotiating site contract and budget, reviewing and approving informed consent and regulatory documents, managing site enrollment, and performing site visits.
  • Managed the development and submission of annual and semi-annual progress reports to the FDA.
  • Authored and implemented department operating procedures and provided training to team members and direct reports.

REGIONAL CLINICAL RESEARCH ASSOCIATE

Advanced Biologics, Inc.
08.2006 - 07.2007
  • Performed site visits including site qualification, initiation, routine monitoring, and closeout visits.
  • Managed US and Canadian investigational centers for a Phase 2B/3 infectious disease clinical trial to ensure site compliance with GCP/ICH guidelines, FDA regulations, and study protocol.

LEAD CLINICAL RESEARCH ASSOCIATE

Medtronic, Inc.
01.2005 - 08.2006
  • Led monitoring for global IDE atrial-fibrillation pacemaker and post-market clinical studies, ensuring site compliance, enrollment, and data integrity.
  • Managed investigator and site selection, CRO oversight, core laboratories, clinical events committees, and regulatory submissions.
  • Trained teams on study protocols, GCP/ICH guidelines, and FDA regulations.
  • Developed study documents, operating procedures, and clinical department metrics to optimize efficiency and compliance.
  • Supervised teams, negotiated contracts, and ensured deliverables met budget and regulatory standards.
  • Contributed to FDA pre-market approval submissions and audit resolution processes.

CLINICAL RESEARCH ASSOCIATE

Medtronic, Inc.
01.2004 - 01.2005
  • Led post-market studies, overseeing study design, protocol development, budget management, and personnel training.
  • Collaborated cross-functionally with sales, marketing, regulatory affairs, and field clinical teams to align clinical goals.
  • Managed clinical sites, including contract negotiations, regulatory approvals, enrollment oversight, and monitoring visits.
  • Directed an independent safety monitoring committee for adverse event adjudication, streamlining reporting and follow-up processes.
  • Authored study reports and contributed abstracts and manuscripts.
  • Participated in corporate task forces to drive process improvements and efficiency.
  • Developed and implemented training for standard operating procedures in the cardiac rhythm management clinical group.
  • Supervised three clinical study coordinators, providing leadership and mentorship.

CLINICAL RESEARCH ASSOCIATE

Boston Scientific
06.2001 - 01.2004
  • Participated in the development of an IDE carotid stenting trial with responsibilities including protocol and CRF preparation, clinical site selection and recruitment, and PMA submission activities.
  • Managed investigational devices for five clinical studies using Boston Scientific product in two distribution centers including labeling, instructions for use, shipments/returns, forecasting, and device accountability. Collaborated with supply chain, distribution centers, and manufacturing.
  • Organized and executed a global corporate process for reporting, tracking, and coding of device complaints and malfunctions for clinical IDE products. Initiated a cross-functional department task force.
  • Oversaw clinical sites with responsibilities including negotiating site contract and budget, reviewing and approving informed consent and regulatory documents, managing site enrollment, and performing monitoring visits.
  • Provided direction to three clinical trial coordinators on study activities.

Education

BACHELOR OF ARTS -

University of Minnesota
Minneapolis, MN
01.2003

Skills

  • Expertise in clinical, regulatory, medical, and quality strategic planning & operations
  • Strong business acumen with a focus on driving results through efficient operating models
  • Analytical thinker with a problem-solving and innovative mindset
  • Dynamic and results-driven leader with proven expertise in guiding cross-functional teams to success
  • Global perspective and ability to navigate complex regulated markets
  • Skilled in driving business development and identifying strategic growth opportunities
  • Experienced in cultivating strong, lasting relationships with key opinion leaders while shaping and executing impactful medical affairs strategies

Affiliations

  • Regulatory Affairs Professional Society
  • AdvaMed
  • Medical Device Innovation Consortium
  • Medical Device Manufacturers Association

Timeline

TEAM MANAGER, MEDTECH BUSINESS CONSULTING

Veeva Systems
12.2021 - Current

VICE PRESIDENT OF CLINICAL AND REGULATORY AFFAIRS

Cardiomech
04.2019 - 12.2022

DIRECTOR OF CLINICAL AFFAIRS

Neuspera Medical
05.2018 - 04.2019

PRINCIPAL PRODUCT DEVELOPMENT STRATEGIST

NAMSA
01.2017 - 05.2018

MANAGER, CLINICAL RESEARCH SERVICES

NAMSA
01.2015 - 01.2017

SR. MEDICAL RESEARCH MANAGER

NAMSA
07.2010 - 01.2015

CLINICAL RESEARCH/STUDY MANAGER

ev3 Endovascular, Inc.
07.2007 - 07.2010

REGIONAL CLINICAL RESEARCH ASSOCIATE

Advanced Biologics, Inc.
08.2006 - 07.2007

LEAD CLINICAL RESEARCH ASSOCIATE

Medtronic, Inc.
01.2005 - 08.2006

CLINICAL RESEARCH ASSOCIATE

Medtronic, Inc.
01.2004 - 01.2005

CLINICAL RESEARCH ASSOCIATE

Boston Scientific
06.2001 - 01.2004

BACHELOR OF ARTS -

University of Minnesota

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