Since 2013, Carla Sivak has been working in SynapDx. Carla is a proficient Vice President Quality and Regulatory with over 22 years of work experience. According to Carla's resume and work profile, Carla Sivak has worked at more than seven places with numerous backgrounds and got various skills. Carla attended school at the University of California, San Francisco. This expert has professional certification in Certified Quality Auditor and Certified Software Quality Engineer. Carla Sivak can be found in Boston, Massachusetts – where this expert is currently located. You can search for Carla's email address and number. We can also provide you additional contact information upon request.
Name variants:
Carlie Sivak,
Carly Sivak
Workplace
Colleagues
Work History
Global Director Quality, Regulatory & Clinical
Mar 2011 — Nov 2012
Director Quality, Regulatory, Clinical
Greater Boston Area
2002 — 2006
Education
Occupations
Executive
Vice President
Professor
School Principal
Chief Executive
School Administrator
Educational Manager
Skills
Teaching Adults
Strategic Leadership
Mentoring
Worldwide Regulations
Clinical Research
Regulatory Affairs
FDA
Business Coaching
Design Control
QSR Quality System Regulation
Quality Auditing
IEC 60601
CE marking
Labeling / Promotional Review
Iso 9000
CAPA
Canadian Regulations (CMDCAS)
Auditing
MDD
ISO 14971
Japanese PAL
V&V
21 CFR 820, 807, 806, 821, 803 ,801 Part 11
Validation
GMP, GLP, GCP
ISO 13485
ICH Q8, ICH Q9, ICH Q10
HIPPA / Worldwide Privacy Regulations
ISO 62304 Med Dev Software Lifecycle
Quality System
Postmarket Survelliance
GCP
Design of Experiments
Product Development
R&D
Medical Device Directive
21 CFR
Medical Devices
FAQs about Carla Sivak
What is the main profession of Carla Sivak?
This professional's job is Medical Devices
What jobs is Carla Sivak proficient at at?
The expert is proficient at such jobs as Executive and Vice President.
Where is Carla Sivak currently located?
The professional is currently located in Boston, Massachusetts.
Where did Carla Sivak work?
Carla worked at SynapDx, Sivak Associates, LLC.
What education does Carla Sivak have?
Carla studied at the University of California, San Francisco.
Are there any certifications, that Carla Sivak has?
The professional received the following certifications: Certified Quality Auditor, Certified Software Quality Engineer, 6 Sigma Green Belt - DMADVV, and Registered Nurse.
What are the skills of Carla Sivak?
This person has the following skills: Teaching Adults, Strategic Leadership, Mentoring, Worldwide Regulations, Clinical Research, Regulatory Affairs, FDA, Business Coaching, and Design Control.