EYONG NKAMANYI
Houston,TX
Summary
Dynamic Regulatory Affairs Specialist with a proven track record at N/a, excelling in regulatory submissions and post-marketing surveillance. Successfully facilitated FDA approvals, enhancing market entry speed. Strong communicator and problem-solver, adept at CAPA management and fostering compliance awareness, ensuring adherence to medical device regulations and labeling requirements.
Thorough team contributor with strong organizational capabilities. Experienced in handling numerous projects at once while ensuring accuracy. Effective at prioritizing tasks and meeting deadlines.
Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Hardworking and passionate job seeker with strong organizational skills eager to secure entry-level [Job Title] position. Ready to help team achieve company goals.
Overview
2
2
years of professional experience
Work History
Regulatory Affairs Specialist
N/a
04.2023 - Current
- Performed and documented quality control checks to maintain compliance with company initiatives.
- Recommended improvements to processes.
- Conducted thorough audits to identify areas of improvement and implement corrective actions for regulatory compliance.
- Facilitated productive communication between company management and regulatory agencies, fostering positive relationships.
- Prepared and submitted regulatory file applications and supporting documentation.
- Assisted in preparation of high-quality submissions for FDA approval, leading to faster market entry for products.
- Provided training to colleagues on regulatory requirements, resulting in increased awareness and overall compliance within the organization.
- Ensured consistency in product labeling by reviewing and approving label designs and promotional materials.
- Received, researched and resolved consumer inquiries.
- Monitored post-market surveillance activities, identifying trends and addressing any potential safety concerns promptly.
- Reviewed advertising materials before release to verify claims were supported by scientific evidence, minimizing potential legal risks.
Education
Bachelor of Science - Zoology
University of Buea
Cameroon08-2010
Skills
- Post-marketing surveillance
- Regulatory submissions
- Labeling and packaging
- CAPA management
- Medical device regulations
- Regulatory policies
- Risk management
- Labeling requirements
Languages
French
Timeline
Regulatory Affairs Specialist
N/a
04.2023 - Current
Bachelor of Science - Zoology
University of Buea
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