Senior Regulatory Affairs Specialist@ Actalent
Austin, Texas, United States
Elissa Calamia
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University of Pittsburgh
Real-Time AI Research
FlashIntel GPT
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FlashIntel GPTElissa Calamia is an International Regulatory Affairs Specialist with 27.6 years of experience in regulatory affairs, medical devices, and technical writing. She has worked at reputable companies such as Abbott, Smith+Nephew, ArthroCare Corporation, DePuy Synthes, and GE Healthcare. Elissa has expertise in global regulatory compliance, medical device directive, adverse event reporting, and quality assurance. She is skilled in cross-functional coordination, GMP, case report forms, clinical monitoring, export documentation, import/export operations, and process improvement. Elissa is based in the United States.
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About
International Regulatory Affairs Specialist
Work Experience
Senior Regulatory Affairs Specialist
Business Consulting and Services
Elissa Calamia's Professional Milestones
- Regulatory Affairs Specialist (2019-07-01~2021-02-01): Managing and drafting comprehensive regulatory standards to ensure compliance and mitigate potential risks.
- Regulatory And Quality Systems COOrdinator (2008-01-01~2012-01-01): Implementing effective regulatory policies and processes to improve compliance and enhance quality systems management.
Education
Skill
Regulatory Affairs
Medical Devices
Regulatory Submissions
Technical Writing
Regulations
Research
Legal Documents
Global Regulatory Compliance
Medical Device Directive
Adverse Event Reporting
Editing
Quality Assurance
Cross Functional Coordination
Gmp
Case Report Forms
Clinical Monitoring
Export Documentation
Import/export Operations
Process Improvement
Certification
Colleagues
Lisa Eckstein
product owner at actalent
Marc (Alex) Miller
connecting life science professionals to leading organizations in cdmo cmo and biologics manufacturing
Kyle Roach
Chief Marketing Officer | PBM Healthcare Services
Kyle Roach
Chief Marketing Officer | PBM Healthcare Services
Josue Camacho
site safety manager owner rep
Other Named Elissa Calamia
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Elissa Calamia works for Actalent
Elissa Calamia's role in Actalent is Senior Regulatory Affairs Specialist
Elissa Calamia works in the industry of Business Consulting and Services
Elissa Calamia's colleagues are Lisa Eckstein,Marc (Alex) Miller,Kyle Roach
Elissa Calamia's latest job experience is Senior Regulatory Affairs Specialist at Actalent
Elissa Calamia's latest education in University of Pittsburgh
