Hello, I'm Melissa T.
Regulatory Affairs Professional with more than 20 years experience in medical devices, including in vitro diagnostic devices (IVDs). Skilled in developing global strategies for marketing authorization of Class II and Class III devices. Authored more than 100 cleared 510(k)s. Skilled technical writer with experience in development and review of labeling including, instructions for use and marketing materials. Regulatory process development and management experience including change assessment for reporting, letters to file, vigilance reporting, inspections/audits, licensing/registration/listings, and more!
Details
- Location
- Years of Relevant Experience20+ years
- Seniority LevelMid-Senior level
- Highest Level of EducationMasters
Current / Most Recent Job Title
Manager, Regulatory Affairs - New Product Introduction & Sustaining
Current / Most Recent Employment
Acumed LLC
Industry
Specific Jurisdictions That I'm Qualified In or Can Cover
Professional Membership / Certification
Regulatory Affairs Professional Society (RAPS) Regulatory Affairs Certified (RAC) - US Regulatory Affairs Certified (RAC) - EU
Skills
Regulatory strategies for market authorization Device classification and justification Risk management Project management Q-Subs/Pre-Subs 510(k) Premarket Approval (PMA) Assessment of changes to approved devices for reporting Letters to File for 510(k) devices Technical Files/ Dossiers/ GSPRs Medical Device Reporting/Vigilance Inspections/Audits Communication with regulatory authorities including US FDA, EU Notified Body, MHRA, Authorized Representatives, Health Canada, ANVISA, AU TGA and more Regulatory process development, training, and management experience Microsoft WORD, Excel, ADOBE, SharePoint, Teams, etc.
Areas of Professional Interest
Development and execution of strategies for new medical devices that improve patient’s lives.