Senior Manager Global Regulatory Affairs@ Beckman Coulter Diagnostics
Brea, California, United States
Annette Hellie
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UC Santa Barbara
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FlashIntel GPTAnnette Hellie is a highly experienced professional with over 20 years of expertise in the GMP/ISO/FDA-regulated in vitro diagnostic (IVD) industry. She has a strong background in global regulatory strategy, submissions, regulatory authority negotiations, labeling, and promotional review. Annette has held various positions at Beckman Coulter Diagnostics, including Director of Quality and Regulatory Affairs and Sr. Manager Global Regulatory Affairs. She is skilled in FDA regulations, medical devices, and regulatory compliance. Annette is based in Brea, California.
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About
Over 20 years experience in a GMP/ISO/FDA-regulated in vitro diagnostic (IVD) industry. Specialties: Global regulatory strategy and submissions, regulatory authority negotiations, labeling and promotional review.
Work Experience
Senior Manager Global Regulatory Affairs
Director Quality and Regulatory Affairs
Medical Equipment Manufacturing
Annette Hellie's Professional Milestones
- Director Quality and Regulatory Affairs (2020-03-01~): Driving legal compliance and securing favorable outcomes through rigorous testing and regulatory compliance.
- Senior Manager Global Regulatory Affairs: Successfully negotiated and executed multiple complex regulatory compliance agreements, ensuring seamless global operations.
Education
Aq. Biology
1986-1990Skill
Fda
Medical Devices
Regulatory Affairs
Iso 13485
Design Control
Regulatory Requirements
Validation
Quality System
Capa
Gmp
Clinical Trials
Assay Development
Lifesciences
Regulatory Submissions
Iso 14971
Product Development
Software Documentation
Pma
Certification
Colleagues
Madina G.
Product Owner
Mehul H.
Leadership | Engineering | Product Owner | Cloud Application Development | Healthcare | Medical Devices | Agile | C# Net | Azure DevOps | Microservices | Rest API | Software Development
Sandeep Gunnam
Engineering Manager | Product Owner
Mehak Jain
Technical Product Manager | Product Owner | Team Leader
Johanna Tournier
Process Owner
Other Named Annette Hellie
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Annette Hellie works for Beckman Coulter Diagnostics
Annette Hellie's role in Beckman Coulter Diagnostics is Senior Manager Global Regulatory Affairs
Annette Hellie works in the industry of Medical Equipment Manufacturing
Annette Hellie's colleagues are Madina G.,Mehul H.,Sandeep Gunnam
Annette Hellie's latest job experience is Senior Manager Global Regulatory Affairs at Beckman Coulter Diagnostics
Annette Hellie's latest education in UC Santa Barbara
