Michael Tomasovich
Senior Regulatory Project Manager & Director of Business Development for Regulatory Affairs Associates (RAA)
- Role
- Quality and Regulatory Affairs Consultant at Clinical Partners Group
- Location
- Livonia, MI, US
- LinkedIn followers
- 500 followers
About Michael Tomasovich
A regulatory affairs professional consultant dedicated to diligently assisting companies and individuals with the development and approval of therapeutics and medical devices at FDA and around the world.Specialties: IND, NDA, BLA, 510K, and PMA submissions; pre-Submission meeting requests and attendance; regulatory product analysis and strategic development; UDI compliance; labeling and promotional material review; QSR development; 21 CFR Part 11 compliance.
Experience
Quality and Regulatory Affairs Consultant
Aug 2021 — Present · Santa Monica, CA, US
Regulatory consultant to various clinical and medical device projects. 510k remediation, FDA pre-sub meetings, RTA responses, 510k submissions, and justifications.
Education
Montcalm Community College
Associate's degree, General Studies
1989 — 1991
Eastern Michigan University
BS, Paralegal Studies
2003 — 2005
Northeastern University
MS, Masters of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices
2008 — 2009
Skills
- Microbiology
- Hardware Diagnostics
- 510 K
- Oncology
- Management
- Pharmaceuticals
- Regulatory Requirements
- Ind
- U.s. Food and Drug Administration (Fda)
- Ctms
- Medical Devices
- Clinical Research
- Capa
- Drug Development
- Gcp
- Biopharmaceuticals
- Regulatory Submissions
- Leadership
- Glp
- Life Sciences
- Strategic Planning
- Regulatory Risk
- CRO
- Commercialization
- 21 Cfr Part 11
- Regulations
- Clinical Trials
- Clinical Development
- Technology Transfer
- Quality Control
- Gmp
- Cross-Functional Team Leadership
- Regulatory Affairs
- Lifesciences
- Validation
- Patents
- Nda
- Business Development
- Start-Ups
- Biochemistry
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