Bilal Chamas
Jacksonville
Summary
An accomplished Regulatory Affairs professional with 9 years of experience in the medical device industry, critical thinker, team builder, skilled communicator, with strong planning and strategizing skills in global regulatory affairs.
Overview
20
20
years of professional experience
Work History
Regulatory Affairs Consultant
Ethicon
Cincinnati
04.2022 - 12.2024
- Authored device technical documentation, GSPRs, and DoCs for the EU per MDR
- Supported the EU MDR remediation project by performing gap assessments on technical files and updating the technical files to bring them into compliance with EU MDR.
- Lead the responses to notified body queries and held cross functional meetings as required.
- Reviewed documentation needed to support the EU MDR submissions
Regulatory Affairs Manager
Ivantis inc.
Irvine
09.2021 - 03.2023
- Managed and prepared PMA supplements such as 30-Day Notices, Real Time Supplements and 180-Day Manufacturing Site Change Supplements, in addition to annual reports for the US
- Authored device technical documentation for the EU per MDR, and other international submissions
- Supported the EU MDR remediation project by performing gap assessments on technical files and updating the technical files to bring them into compliance with EU MDR.
- Supported international distributors and provided them with information needed for license renewals, new registrations and registration maintenance
- Reviewed and approved change orders
- Provided regulatory assessments for manufacturing and design changes and promotional material for each global market
- Represented regulatory affairs in product development projects
- Ordered Certificates of Foreign Government
- Apostilled and legalized documents when needed
- Supported the manufacturing site change project
- Reviewed reports and validations for scientific merit and regulatory appropriateness
Regulatory Affairs Project Manager
Ivantis inc.
Irvine
03.2020 - 09.2021
- Managed and prepared PMA supplements such as 30-Day Notices, Real Time Supplements and 180-Day Manufacturing Site Change Supplements, in addition to annual reports for the US
- Authored, maintained and updated device technical files / technical documentation for the EU per MDD and MDR, and other international submissions
- Supported the EU MDR remediation project by performing gap assessments on technical files and updating the technical files to bring them into compliance with EU MDR.
- Supported international distributors and provided them with information needed for license renewals, new registrations and registration maintenance
- Reviewed and approved change orders
- Provided regulatory assessments for manufacturing and design changes and promotional material for each global market
- Represented regulatory affairs in product development projects
- Ordered Certificates of Foreign Government
- Apostilled and legalized documents when needed
- Supported the manufacturing site change project
- Authored, maintained and updated device technical files / technical documentation
- Reviewed complex reports, and validations for scientific merit and regulatory appropriateness
Regulatory Affairs Specialist
Ivantis inc.
Irvine
04.2019 - 03.2020
- Managed and prepared PMA supplements such as 30-Day Notices, Real Time Supplements and 180-Day Manufacturing Site Change Supplements, in addition to annual reports for the US
- Maintained and updated technical files for the EU, and other international submissions
- Supported the EU MDR remediation project by performing gap assessments on technical files and updating the technical files to bring them into compliance with EU MDR.
- Supported international distributors and provided them with information needed for license renewals, new registrations and registration maintenance
- Reviewed and approved change orders
- Provided regulatory assessments for manufacturing and design changes and promotional material for each global market
- Ordered Certificates of Foreign Government
- Apostilled and legalized documents when needed
- Supported the manufacturing site change project
- Reviewed reports and validations for scientific merit and regulatory appropriateness
Regulatory Affairs Specialist
Balt USA
Irvine
11.2017 - 03.2019
- Managed and prepared 510(k) submissions for the US
- Authored and maintained technical files for the EU per MDD and MDR, and other international submissions
- Supported the EU MDR remediation project by performing gap assessments on technical files and updating the technical files to bring them into compliance with EU MDR.
- Supported international distributors and provided them with information needed for license renewals, new registrations and registration maintenance
- Reviewed and approved change orders
- Provided regulatory assessments for manufacturing and design changes and promotional material for each global market
- Prepared LTF’s for changes to 510(k) products
- Represented regulatory affairs in product development projects
- Ordered Certificates of Foreign Government for several lines of products
- Apostilled and legalized documents when needed
- Supported the name change and manufacturing site change project
- Reviewed reports and validations for scientific merit and regulatory appropriateness
Regulatory Affairs Specialist
Abbott Medical Optics
Santa Ana
05.2017 - 10.2017
- Supported international affiliates and provided them with information needed for license renewals and registration maintenance
- Ordered Certificates of Foreign Government for several lines of products
- Apostilled and legalized documents when needed
- Supported the name change project following the acquisition by Johnson & Johnson
- Communicated effectively and in a timely manner with international affiliates to keep them up to date with the status of their request
Regulatory Affairs Specialist I
Medtronic
Goleta
02.2017 - 05.2017
- Converted Technical Documents and Design Dossiers to STED format
- Create STEDs for new products
- Summarized technical reports and scientific documents
- Collaborated with coworkers to acquire information needed to complete the STEDs
- Planned and organized timelines for completion of tasks in hand
Regulatory Affairs Specialist II
St. Jude Medical
Irvine
03.2015 - 11.2016
- Managed and prepared PMA supplements such as 30-Day Notices and Real Time Supplements, in addition to annual reports for the US
- Authored and maintained technical files for the EU per MDD, and other international submissions
- Reviewed and approved change orders
- Provided regulatory assessments for manufacturing and design changes and promotional material for each global market
- Prepared LTF’s for changes to 510(k) products
- Represented regulatory affairs in product development projects
- Reviewed complex reports, and validations for scientific merit and regulatory appropriateness
Regulatory Affairs Associate
Allergan Medical
Goleta
02.2013 - 11.2014
- Managed and prepared PMA supplements such as 30-Day Notices for the US
- Maintained technical files for the EU per MDD
- Participated in global teams, interpreting regulations and providing regulatory guidance
- Prepared administrative and scientific documents for internal and external customers
- Worked with team to resolve complex project issues
- Maintained and updated device technical files
- Reviewed reports and validations for scientific merit and regulatory appropriateness
Microbiologist
Meissner Filtration Products
Camarillo
12.2012 - 02.2013
- Performed LAL endotoxin testing on DI water and filter samples.
- Calibrated on-site pressure gauges and replaced filters as needed
- Cryopreserved bacteria and operated the spectrophotometer
- Challenged and tested filter membranes for compatibility and integrity
- Ordered lab supplies
- Prepared cultural media, and operated the autoclave
- Performed water collection and bioburden testing
- Performed Environmental Monitoring testing using an air sampler and contact plates
- Performed growth promotion and identified bacterial colonies using gram staining and oxidase and catalase tests
- Assured that equipment used is calibrated and performing properly
Microbiologist
Johnson & Johnson
Los Angeles
06.2010 - 05.2012
- Prepared cultural media, and operated the autoclave
- Performed water collection and bioburden testing
- Performed Environmental Monitoring Testing
- Performed growth promotion and gram staining
- Plated a variety of samples for microbiological testing
- Assured that equipment used is calibrated and performing properly
- Conducted Test Method Suitability Studies.
Microbiologist
Levlad Inc.
Chatsworth
11.2008 - 05.2010
- Prepared cultural media, and operated the autoclave
- Performed water collection and testing
- Performed growth promotion and gram staining
- Plated bulks, raw materials, and finished goods for microbiological testing
- Ordered lab supplies and equipment from company’s supplier
- Quality Control Chemist
- Perform chemical and physical analysis of bulk formulations, finished goods, and raw materials to determine their viscosity, pH, specific gravity, melting point, % solid, and polyethylene percentage
- Conducted pH and viscosity adjustments on bulk formulations that fell out of spec and required adjustments
- Followed GLP and GMP regulations in performing product testing and documentation of raw data
- Inputted and organized data on the computer
- Conducted assigned projects that required me to work both in groups and individually
- Assisted in maintaining and calibrating various lab equipment
- Ordered lab supplies and equipment from the company’s supplier
Pharmacy Assistant Volunteer
MICKEY FINE PHARMACY
Beverly Hills
01.2005 - 01.2007
- Contacted third-party insurance providers to obtain payments for corresponding prescriptions
- Interacted with patients and healthcare professionals at the pharmacy window or via the telephone to ensure customers satisfaction
- Assisted the Pharmacist by pre-packing medications and insulin syringes
- Reviewed patient computer files and checked for correct insurance and refill information
- Assisted in ordering, and stocking prescription and over-the-counter medications, as well as tracking inventory
Education
B.S. - Biochemistry
University of California, Los Angeles
Los Angeles, CA06.2008
Emphasis - Pre-Pharmacy
Santa Monica College
Santa Monica, CA06.2006
Skills
- MS Word
- MS Excel
- MS Power Point
- FDA (21 CFR)
- EU MDD
- EU MDR
Skills Certifications
MS Word, MS Excel, MS Power Point, GIS for Health, Visual Molecular Dynamics, Member of the Regulatory Affairs Professional Society (RAPS), CAPA management certification through Pathwise (2014)
Timeline
Regulatory Affairs Consultant
Ethicon
04.2022 - 12.2024
Regulatory Affairs Manager
Ivantis inc.
09.2021 - 03.2023
Regulatory Affairs Project Manager
Ivantis inc.
03.2020 - 09.2021
Regulatory Affairs Specialist
Ivantis inc.
04.2019 - 03.2020
Regulatory Affairs Specialist
Balt USA
11.2017 - 03.2019
Regulatory Affairs Specialist
Abbott Medical Optics
05.2017 - 10.2017
Regulatory Affairs Specialist I
Medtronic
02.2017 - 05.2017
Regulatory Affairs Specialist II
St. Jude Medical
03.2015 - 11.2016
Regulatory Affairs Associate
Allergan Medical
02.2013 - 11.2014
Microbiologist
Meissner Filtration Products
12.2012 - 02.2013
Microbiologist
Johnson & Johnson
06.2010 - 05.2012
Microbiologist
Levlad Inc.
11.2008 - 05.2010
Pharmacy Assistant Volunteer
MICKEY FINE PHARMACY
01.2005 - 01.2007
B.S. - Biochemistry
University of California, Los Angeles
Emphasis - Pre-Pharmacy
Santa Monica College