Go to top of page
Close
 
Close
Back

Administrative Assistant / Regulatory Affairs Associate / Sr. Unique Device Identifier Specialist (Labeling) / Legal Administrative Assistant / Regulatory & Compliance Coordinator Santa Clarita Resume

Administrative Assistant / Regulatory Affairs Associate / Sr. Unique Device Identifier Specialist (Labeling) / Legal Administrative Assistant / Regulatory & Compliance Coordinator Santa Clarita Resume

« Back to Jobs Home
Seeking Job: Administrative Assistant / Regulatory Affairs Associate / Sr. Unique Device Identifier Specialist (L
Position Desired: Administrative Assistant / Regulatory Affairs Associate / Sr. Unique Device Identifier Specialist (L

Cover Letter:
ABOUT ME

I am Strategic, detail-oriented Professional offering expertise in ensuring that, processes, and operations are aligned with industry regulations, professional business partner, quick learner, and dynamic project manager known for building strong relationships with internal / external partners at all levels to assess processes to ensure adherence to policies and guidelines. Collaborative leader and effective communicator with demonstrated successes in partnering with cross-functional teams to identify key areas of deficiency, design / implement policies to address gaps and maintain databases, to exceed business, delivery, and financial expectations.

CORE COMPETENCIES

Industries - Medical Device, Legal / Law / Clinical Affairs / Marketing / Requirements Assessments / Troubleshooting Quality Assurance / Risk Mitigation / Compliance / Process Improvements / Reporting  Documentation

TECHNICAL PROFICIENCIES

Software Tools / Databases  Salesforce  Microsoft Office  Adobe UDI (GUDID, EUDAMED) Databases  GS1 UDI Portal Hub  US FDA Furls Registration / Device Listing  Legal Research / Writing 

CERTIFICATIONS

• Certified in FDA UDI Standards and MDR UDI and Labeling, GS1 US University, New Jersey
• Certified Notary, California Secretary of State / Certified Loan Signing Agent, Chatsworth, CA
• Certified Paralegal, Merit College, Van Nuys, CA

EXPERIENCE

BIONESS INC., Valencia, CA 4/2010 - 7/2021

Senior UDI Specialist | Regulatory Affairs Associate, 2/2016 – 7/2021

• Managed UDI implementation project (FDA and EUDAMED)
• Developed procedures and training materials
• Partnered with the preparation of 510(k) regulatory submissions, technical files
• Orchestrated the annual renewal of the establishment registration and medical device listing with the FDA.
• Notarized and legalized CFGs / Certificates of Free Sale and prepared / processed Apostilles
• Man

Contact Form Only Available to Registered SantaClarita.com Members.
Contact Information:
Contact:
Only Visible to Registered SantaClarita.com Members.

Phone:
Only Visible to Registered SantaClarita.com Members.

Email Contact Only Available to Registered SantaClarita.com Members.

Last Updated: Oct 25, 2021 @ 1:12pm



« Back to Jobs Home








TownHub