Diane Reed
Global Regulatory Affairs | Regulatory Strategy | Medical Devices | Pharmaceuticals | Combination Products | Product Development | Lifecycle Management
- Role
- Principal Consultant, Regulatory Affairs at Suttons Creek
- Location
- Denver, CO, US
- LinkedIn followers
- 500 followers
About Diane Reed
As a Principal Consultant at Suttons Creek, Inc, I bring extensive experience in…
Experience
Principal Consultant, Regulatory Affairs
May 2024 — Present · Denver, CO, US
Provide regulatory and other expertise to clients for a variety of drug-led combination products as well as participate in company-wide initiatives such as new hire training and eCTD templates. Manage medical device regulatory aspects for eCTD submissions, develop regulatory strategies, assess changes, and interact with Health Authorities in the US.
Education
Gonzaga University
Bachelor of Arts (BA), Psychology and Elementary Education
Colorado School of Mines
Bachelor of Science (BS) Chemistry with Chemical Engineering Minor
Skills
- Medical Devices
- Capa
- Regulatory Requirements
- Ind
- Biotechnology
- Ce Marking
- 21 Cfr
- 21 Cfr Part 11
- Iso
- Pharmaceutical Industry
- Sop
- Fda
- Corrective and Preventive Action (Capa)
- Glp
- Quality System
- V&V
- Psi Seminars (Personal and Professional Development Programs), 2006
- Quality Control
- Change Control
- Gmp
- Technology Transfer
- Cmc Regulatory Affairs
- Analytical Chemistry
- Verification and Validation (V&V)
- Quality Auditing
- Design Control
- Ectd
- Standard Operating Procedure (Sop)
- U.s. Food and Drug Administration (Fda)
- Iso 14971
- Technical Writing
- Clinical Trials
- Quality Assurance
- Rocky Mountain Regulatory Affairs Society
- Regulatory Affairs
- Lifesciences
- Certified Yoga Instructor
- Regulatory Affairs Professional Society (Raps)
- Nda
- Validation
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