Idrees
- Role
- Staff Regulatory Affairs Specialist at Beckman Coulter Diagnostics
- Location
- Bayonne, NJ, US
- LinkedIn followers
- 500 followers
About Idrees
Accomplished Regulatory Affairs Specialist with extensive experience in leading global…
Experience
Staff Regulatory Affairs Specialist
Jan 2023 — Present · Chaska, MN, US
Spearheaded preparation of CE marking of documentation under IVDD 98/79/EC and IVDR 2017/746, enabling timely EU market access for 12 + IVD products with zero non-compliances.• Authored and submitted 5 FDA 510(k) dossiers via eStar accelerating approval timeline by 20% through optimized assay performance data presentation and gap-free regulatory content.• Led regulatory impact assessment for 30+ design changes in CCB meetings ensuring global compliance and mitigating post market risk across U.S. and EU territories.• Conducted comprehensive reviews of IFUs. Labeling and GHS documentation, achieving alignment with FDA 21 CFR part 801and ISO 15223-1 across all product lines.
Education
University of the Punjab
B.Sc., Biology, Chemistry
1974 — 1976
University of the Punjab
M.Sc., Chemistry
1976 — 1979
Skills
- Cell Based Assays
- Analytical Chemistry
- Laboratory Automation
- Diagnostics
- Cell Culture
- Clinical Trials
- Elisa
- Chromatography
- Cgmp
- R&D
- Pharmaceutical Industry
- Sop
- Fda
- Biotechnology
- Technology Transfer
- Immunoassays
- Design Control
- Regulatory Affairs
- Lifesciences
- Purification
- Laboratory
- Chemistry
- Design of Experiments
- Biochemistry
- Infectious Diseases
- Iso 13485
- New Product Validation
- Uv/Vis
- Immunology
- Assay Development
- Glp
- Pcr
- Quality System
- V&V
- Molecular Biology
- Commercialization
- Biomedical Engineering
- Validation
- Quality Assurance
- Testing
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