Michael Venezia
Senior Regulatory Affairs Specialist at Enable Injections
- Role
- Senior Regulatory Affairs Specialist at Enable Injections, Inc.
- Location
- Indianapolis, IN, US
- LinkedIn followers
- 500 followers
About Michael Venezia
Currently: Senior Regulatory Affairs Specialist - Enable Injections.Previously: Regulatory Affairs Specialist - Cook MedicalPreviously: Regulatory Specialist - Indiana University School of Medicine Previously: Regulatory Submissions Coordinator - MedpacePreviously: Global Regulatory Affairs Intern - Ipsen Biopharmaceuticals2018 Masters of Regulatory Sciences from Johns Hopkins University2016 Bachelors in Arts from Wabash College - Major: History, Minor: Biology
Experience
Senior Regulatory Affairs Specialist
Sep 2022 — Present
Participate in Enable cross-functional teams as the Regulatory Affairs SME; provide regulatory strategy guidance, assess regulatory notification requirements of platform changes, etc.• Represent Enable as the primary Regulatory Lead and Point of Contact for partner programs as necessary;• Prepare responses to requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires;• Recommend and implement changes to company procedures in response to changes in regulations or standards;• Ensure compliance with regulations set by ISO 13485, 21 CFR 820, Medical Device Directive / Medication Device Regulations, and other key global requirements;• Prepare and maintain master files, technical files, or other regulatory submissions as necessary to obtain and sustain finished product approval in the US and global markets;• Prepare documentation needed to support investigational clinical studies conducted in the US (IND, IDE) or globally• Prepare or direct the preparation of additional information or responses as requested by regulatory agencies;• Outline requirements for labelling, storage, and packaging;• Support post-market surveillance obligations in accordance with applicable US and global regulatory requirements (including MDR).
Education
Cathedral High School
High School Diploma
Wabash College
Bachelors in Arts, History and Biology
2012 — 2016
Johns Hopkins University Advanced Academic Programs
Master of Science - MS, Regulatory Affairs
2016 — 2018
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