Shola Sulaimon
Santa Rosa,USA
Summary
Clinical and Regulatory Leader in Medical Technology with 10+ years of experience overseeing global clinical and medical writing programs, obtaining CE Mark approvals, and facilitating market access through strategic partnerships that have led to the adoption of cardiovascular and surgical valve devices across Europe. Demonstrated success in managing complex research projects and clinical trials, as well as directing cross-functional teams towards project objectives. Expertise in strategic planning and stakeholder engagement has consistently ensured timely and successful project delivery. Dedicated to advancing research initiatives that achieve tangible outcomes, expedite regulatory approval processes, and enhance patient access worldwide.
Overview
19
19
years of professional experience
Work History
SR. CLINICAL RESEARCH PROGRAM MANAGER
Medtronic PLC
02.2021 - 07.2025
- Provided strategic planning and operational leadership to develop and implement program strategies and processes for a $1B global business—aligning program goals with corporate objectives and tracking progress against operating unit targets.
- Led 100 forecasting and Annual Operating Plan (AOP) management for a $5.5M clinical operating budget, ensuring financial alignment with strategic objectives.
- Led process improvement and efficiency efforts enabling project teams to generate and disseminate clinical evidence with the highest quality, timely delivery and cost effective.
- Increased closure of notified body queries by deficiency round 2.
- Built strong relationships with stakeholders and cross-functional leaders across Clinical, Regulatory, R&D, Quality, and Marketing within the broader organization.
- Conducted briefings with senior leadership on operations and strategic initiatives as well critical program outcomes.
- As EU-MDR Clinical Core Team Lead, led and shaped strategy for a 58-member global team managing regulatory submissions and CE mark approval in Europe, working across clinical, biostatistics, and medical writing on study planning, evidence generation, analysis, and reporting.
- Responsible for technical review and submission integrity of generated documents consisting of Clinical Evidence Plans, Clinical Evidence Reports, Post Market Clinical Follow Up Plans, Post Market Clinical Follow Up Reports, and Summary of Safety and Clinical Performance.
- Delivered 100% completion of clinical documentation supporting 53 EU-MDR Technical Files, resulting in European approval and CE certification of Class I, II, & III medical devices encompassing the surgical valves therapy extracorporeal, therapy, revascularization and surgical ablation, and blood management products.
MEDICAL WRITING MANAGER
Medtronic PLC
07.2017 - 01.2021
- Responsible for staff hiring, talent development & retention, performance evaluation, goal settings and employee feedback for Coronary & Renal Denervation and Cardiac Surgery & Structural Heart product portfolio, a $4B business.
- Led a 9-member global team—including members in Europe and China—of experienced medical writers and contractors to disseminate clinical evidence for the Coronary and Renal Denervation product portfolio.
- Trained diverse clinical teams on regulations from various geographies, including the European Union, Therapeutic Good Administration, and the China Food & Drug Administration.
PRINCIPAL MEDICAL WRITER
Medtronic PLC
05.2016 - 06.2017
- Recruited to oversee the clinical evaluation and clinical evidence dissemination for Coronary & Renal Denervation product portfolio generating $1B/year, including clinical data analysis and scientific reports for regulatory submissions.
- Compiled, analyzed, and condensed additional data such as complaint/vigilance data, risk management documentation, and scientific literature.
- Engaged in post-market surveillance activities, including literature review, extracting data, and screening articles against inclusion/exclusion criteria.
- Ensured compliance with regulatory guidance for CERs and essential safety and performance requirements outlined in Annex I of the Medical Device Directive 93/42/EEC, as per MEDDEV 2.7/1 Rev 4, MEDDEV 2.12, MEDDEV 2.4/1 Rev 9, and EN ISO 14155.
PRINCIPAL CLINICAL RESEARCH SPECIALIST
Medtronic PLC
01.2012 - 04.2016
- Served as the Clinical Study Manager for PROTECT CA and Symplicity Heart Failure study, overseeing project schedules, dashboards, timelines, databases, CSRs, APRs, and study-specific SOPs from initiation to closeout.
- Oversaw CRO service commitments in accordance with the contract while monitoring milestones and presenting project updates and key timelines to cross-functional team members and the CROs.
- Provided critical guidance and assistance for process improvement initiatives supporting the operational launch of the Clinical CSH integration.
PRINCIPAL SCIENTIST
Medtronic PLC
01.2007 - 07.2011
ADJUNCT FACULTY
Sonoma State University (SSU)
CA, USA
08.2006 - 06.2007
ADJUNCT FACULTY
Santa Rosa Junior College (SRJC)
CA, USA
08.2006 - 06.2007
Education
Ph. D. - Clinical Sciences
University of Illinois
Urbana, Champaign, ILM.Sc. - Clinical Sciences
University of Illinois
Urbana, Champaign, ILDoctor of Veterinary Medicine (DVM) -
University of Maiduguri
NigeriaPMP - Professional Program in Project Management
University of California, Berkeley
CASkills
- Clinical Research
- Clinical Development
- Strategic Planning & Operational Direction
- Program Management
- Medical Device (Class I, II, III)
- Regulatory Affairs
- Quality
- Compliance
- European Medical Device Regulations (EU-MDR)
- Regulatory Inspections/Audits
- Risk Assessment & Mitigation
- Process Improvement
- Global Operations
- C-Suite Communications
- Stakeholders Management
- CRO & Vendor Relationships
- Budgeting & Forecasting
- Organizational Goals Setting
- People & Team Leadership
- Training Delivery
- Coaching
- Mentorship
- Non-profit Board of Directors
Timeline
SR. CLINICAL RESEARCH PROGRAM MANAGER
Medtronic PLC
02.2021 - 07.2025
MEDICAL WRITING MANAGER
Medtronic PLC
07.2017 - 01.2021
PRINCIPAL MEDICAL WRITER
Medtronic PLC
05.2016 - 06.2017
PRINCIPAL CLINICAL RESEARCH SPECIALIST
Medtronic PLC
01.2012 - 04.2016
PRINCIPAL SCIENTIST
Medtronic PLC
01.2007 - 07.2011
ADJUNCT FACULTY
Sonoma State University (SSU)
08.2006 - 06.2007
ADJUNCT FACULTY
Santa Rosa Junior College (SRJC)
08.2006 - 06.2007
Ph. D. - Clinical Sciences
University of Illinois
M.Sc. - Clinical Sciences
University of Illinois
Doctor of Veterinary Medicine (DVM) -
University of Maiduguri
PMP - Professional Program in Project Management
University of California, Berkeley
Similar Profiles
Shola SulaimonShola Sulaimon
SR. CLINICAL RESEARCH PROGRAM MANAGER, Cardiac Surgery, Clinical Research & Medical Science at Medtronic PLCSR. CLINICAL RESEARCH PROGRAM MANAGER, Cardiac Surgery, Clinical Research & Medical Science at Medtronic PLC
Venkatam KalyanasundaramVenkatam Kalyanasundaram
Principal Financial Analyst at Medtronic PLCPrincipal Financial Analyst at Medtronic PLC
Frankie N. IglesiasFrankie N. Iglesias
Principal Engineer at Medtronic PLCPrincipal Engineer at Medtronic PLC
Iana VovkIana Vovk
Restaurant General Manager at Glacier Restaurant Group & Foley Entertainment Group (Chalkboard, Goodnights, Arandas)Restaurant General Manager at Glacier Restaurant Group & Foley Entertainment Group (Chalkboard, Goodnights, Arandas)
Emily V. RojasEmily V. Rojas
Cashier/server at Nick the GreekCashier/server at Nick the Greek