Summary
Overview
Work History
Education
Skills
Affiliations
Certification
Languages
Timeline
Generic

KLINNSMAN FOMINYAM

KATY,TX

Summary

Results-driven regulatory professional with extensive experience of about 4+ years in leading PMA and 510(k) submissions for medical devices. Skilled in coordinating teams to ensure compliance with global regulations and maintaining technical files per ISO 13485 and FDA standards. Proficient in integrating risk management activities into Agile workflows and managing Design Verification and Validation (V&V) processes. Committed to enhancing product safety through effective post-market surveillance and cybersecurity measures, with a proven track record in conducting regulatory audits and improving compliance standards.

Overview

5
5
years of professional experience
1
1
Certification

Work History

Medical device regulatory affairs specialist

Cube Hub Inc
06.2022 - Current
  • Led the development and submission of PMA applications and 12 successful 510(k)s for Class III medical devices, ensuring full compliance with FDA and EU MDR requirements, resulting in a 20% faster certification process.
  • Coordinated with interdisciplinary teams to review and update 15+ product technical files, ensuring compliance with global regulations. Prepared and maintained technical and design history files in accordance with ISO 13485 and FDA standards.
  • Managed clinical trial protocols and submissions, including Investigational Device Exemption (IDE) applications, to support safety and efficacy claims for ICDs.
  • Conducted risk assessments and developed risk management plans in compliance with ISO 14971, including FMEA for the ICD.
  • Established and executed post-market surveillance plans, including the management of Medical Device Reports (MDRs) to monitor device performance.
  • Led internal and external regulatory audits, resolving non-compliance issues and improving adherence to regulatory standards. Implemented an internal audit that increased departmental compliance by 10%.
  • Collaborated with engineering, quality assurance, and manufacturing teams to align product development with regulatory requirements.


Certified Scrum Master, CSM

ARC-ONE SOLUTIONS
01.2020 - 05.2022
  • Led Agile sprints for Class III medical devices, ensuring regulatory compliance was integrated throughout the development cycle. Collaborated with the regulatory affairs team to align with FDA 21 CFR Part 820, EU MDR 2017/745, and international standards like ISO 13485.
  • Integrated risk management activities, including hazard analysis and Failure Mode Effects Analysis (FMEA), into the Agile workflow for Class III devices. Each sprint focused on risk mitigation tasks, with regular updates to the risk management file to ensure compliance with regulatory requirements.
  • Facilitated Agile Scrum ceremonies, ensuring cross-functional team collaboration and adherence to project timelines, which resulted in a 20% improvement in project delivery speed while maintaining compliance with FDA medical device regulations.
  • Led sprints centered on Design Verification and Validation (V&V) processes, facilitating the creation of test cases and validation plans to meet regulatory documentation requirements.
  • Oversaw sprint planning and execution for biocompatibility testing (ISO 10993), electromagnetic compatibility (EMC), and electrical safety testing (IEC 60601). Ensured thorough documentation of testing activities for regulatory submission.
  • Integrated human factors engineering tasks into Agile processes, ensuring usability testing and design improvements aligned with IEC 62366. Facilitated feedback loops to minimize user error, crucial for Class III device compliance.
  • Directed cross-functional agile teams in achieving project milestones under stringent regulatory compliance, enhancing project delivery timelines by 25% while ensuring adherence to medical device regulations and standards such as ISO 13485 and FDA 21 CFR Part 820.
  • Integrated post-market surveillance into Agile workflows, enabling real-time device monitoring and adverse event reporting via the FDA's and EU MDR systems.

Education

Bachelors of Medical Laboratory Science -

Saint Monica University
07.2018

Skills

  • Strong leadership and organizational skills with the ability to lead scientific teams under pressure and ensure timely project completion
  • Expertise in ensuring compliance with FDA Quality System Regulations (QSR) for medical devices
  • Proven experience managing regulatory processes, including CE Mark, PMA, 510(k), post-marketing surveillance, and CAPA management, with a focus on ISO standards and audits
  • Proficient in managing SDLC using Agile methodologies like Scrum and Kanban, with experience in tools such as JIRA, Confluence, and Azure DevOps for efficient project execution
  • Experienced in integrating risk management (FMEA) into Agile workflows and leading Design Verification and Validation (V&V) processes for ISO 14971, FDA, and EU MDR compliance

Affiliations

  • Medical Laboratory Science Society
  • The Association of Microbiology
  • Scrum/Agile Alliance Society

Certification

Certified Project Management (CPM) Pending

Cyber Compliance and Governance, 2022

Certified Scrum Master, (CSM), 2020

Certified Pharmacy Technician (CPhT), 2019

Medical Laboratory Technologist Practice Permit, 2018

Languages

English
Native or Bilingual
French
Native or Bilingual

Timeline

Medical device regulatory affairs specialist

Cube Hub Inc
06.2022 - Current

Certified Scrum Master, CSM

ARC-ONE SOLUTIONS
01.2020 - 05.2022

Bachelors of Medical Laboratory Science -

Saint Monica University

Similar Profiles

CREATE PROFILE
KLINNSMAN FOMINYAM