Bryan Sowatzke
Regulatory Affairs Manager at Orascoptic
- Role
- Regulatory Affairs Manager at Promega Corporation
- Location
- Madison, WI, US
- LinkedIn followers
- 500 followers
About Bryan Sowatzke
Regulatory Affairs Professional with global Pre and Post market medical device experience. Background includes 510(k), CE Marking, China and other global market device registrations, global complaint handling and reporting, risk assessments, promotional and marketing material reviews, interfacing with Regulatory Authorities with mentoring and training skills. An established authority on global regulations.Specialties: Finding solutions to meeting requirements that are most profitable for the business. Committed to maximizing profits and positioning the company for future growth.
Experience
Regulatory Affairs Manager
May 2013 — Present
Manage regulatory activities for pre and post market compliance for Promega.
Education
Keller Graduate School of Management of DeVry University
Master's degree, Project Management
2003 — 2006
Lakeland University
BA, Business Administration
1994 — 2000
Skills
- Iso 14971
- Regulatory Affairs
- Iso
- Pharmaceutical Industry
- Fda
- Design Control
- Gmp
- 21 Cfr Part 11
- Regulations
- Glp
- Verification and Validation (V&V)
- Biotechnology
- Ce Marking
- Validation
- Corrective and Preventive Action (Capa)
- Quality Assurance
- Regulatory Requirements
- Quality Auditing
- Recalls
- Complaint Management
- Regulatory Submissions
- Iso 13485
- Medical Devices
- Capa
- U.s. Food and Drug Administration (Fda)
- R&D
- Manufacturing
- Fda Gmp
- Change Control
- Product Development
- Quality System
- V&V
- Iso Standards
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