Dornatien Anang, PhD
Edmonton
Summary
Seasoned Regulatory Affairs Manager with over three years in developing effective processes and executing regulatory affairs initiatives for medical device industry. Improved processes and assisted product development in meeting regulatory requirements. Maintained and followed up on records of regulatory information and submissions.
Overview
2
2
years of professional experience
Work History
Regulatory Affairs Manager
GenDx
06.2024 - Current
- Worked with governance committees to make and evaluate plans.
- Kept abreast of evolving industry trends, allowing the company to adapt quickly to changes in the regulatory landscape.
- Performed and documented quality control checks to maintain compliance with company initiatives.
- Recommended improvements to processes.
Regulatory Affairs Specialist
Amsterdam UMC
10.2022 - 05.2024
- 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.
- Maintained detailed records of all regulatory activities, enabling quick access during inspections or audits.
- Participated in negotiations with regulators during inspections or audits, advocating on behalf of the company''s best interests while respecting agency expectations.
- Prepared and submitted regulatory file applications and supporting documentation.
- Provided training to colleagues on regulatory requirements, resulting in increased awareness and overall compliance within the organization.
Education
Ph.D. - Medical Sciences
University of Amsterdam
Amsterdam, Netherlands10.2022
Master of Science - Medical Sciences
Maastricht University
Netherlands07.2018
Skills
- Regulatory Submissions
- Regulatory Strategy
- Labeling Compliance
- Clinical Trial Oversight
- Medical Device Regulations
- Regulatory Policies
- GxP Knowledge
- Regulatory Agency Applications
- ISO Standards
- Technical Writing
- Clinical Development
- Pharmaceutical Industry
- FDA Interactions
Languages
English
Native language
French
Advanced
C1
Dutch
Advanced
C1
Timeline
Regulatory Affairs Manager
GenDx
06.2024 - Current
Regulatory Affairs Specialist
Amsterdam UMC
10.2022 - 05.2024
Ph.D. - Medical Sciences
University of Amsterdam
Master of Science - Medical Sciences
Maastricht University
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