MARINA K. BULL
AlloSource
Highlands Ranch,CO
18
years of professional experience
Dedicated and focused medical device and pharmaceutical professional with great depth and breadth of experience from product development through commercial release. Successful coordination and completion of regulatory submissions (510k, etc.) and execution of compliance related activities.
Work History
Research and Development Specialist
10 Years 1 Month- Constructed submission files for regulatory authority review
- Provides regulatory support for product development
- Performs regulatory aspects of submission processes (510(k) and BLA)
- Drives cross-functional alignment during projects focused proactively on issues that could have regulatory ramifications
- Reviews validation reports for regulatory submission soundness
- Worked closely with Regulatory and Quality to maintain optimum levels of communication to effectively and efficiently complete projects
- Conducted engineering and detailed experimental tests to collect design data and assist in research work
- Generated engineering and technical documentation to facilitate product development collaboration.
Quality Assurance Engineer
1 Year 6 Months- Gathered data on integration issues and vulnerabilities and outlined improvement recommendations
- Proposed development and testing improvements to positively impact usability, function, and performance
- Drove corrective and preventive actions at leadership level to accomplish project closure and recurrence control, providing necessary resources and clearing roadblocks
- Assist in failure investigations of non-complaint product for Corrective and Preventive Actions and Non-Conformances.
Biologic Specialist
3 Years 10 Months- Assisted operations with FDA regulations to enforce quality and safety to maintain compliance standards for an FDA 21 CFR part 211 product
- Drove improvements for biologic tissue processing and technician support
- Evaluated collected data points from cellular experiments to produce summary reports for biologic tissue processing
- Documented experiment progress and observations, compiled data, and organized findings for analysis
- Helped scientific and engineering teams improve research by sharing regulatory and quality knowledge
- Tested chemical products to monitor reactions for quality assurance purposes.
Certified Veterinary Technician
3 Years 4 Months- Conducted two clinical trials for FDA for experimental pharmaceutical: Tildren
- Evaluated and executed studies in accordance with Regulatory and Quality standards: Tildren
- Recorded symptoms and documented medical observations to provides accurate clinical data: Tildren
Education
Associate of Science - Veterinary Technology
Associate of Arts - Business Administration
Bachelor of Science
Skills
Data organization
Medical Device and Pharmaceutical background
Well versed with FDA regulatory guidelines applicable to tissue banking 21 CFR Part 1271
medical device 21 CFR Part 820
and biologic 21 CFR Part 211 regulations
Adept regulatory lead for cross functional project teams
Researches scientific regulatory skills to propose strategies on complex issues
Compiles
reviews
and submits regulatory submission to authorities
Provides recommendations on manufacturing
analytical and clinical study plans for regulatory compliance.
Patents
- Permeable Pouch for Tissue Containment (20160228231)
- Rapid Allograft Treatment and Methods (20170035937)
- Consistent Calcium Content (20180104381)
- Rapid Acoustic Tissue Processing Methods and Systems (20180280575)
- System and Methods of Use for Preparing and Testing Pre-Sutured Tendon Constructs (10,217,964)
- Adjustable Pre-Sutured Allograft Construct (17/712,430)
Affiliations
- AATB – American Association of Tissue Banks Affiliations
- BRASS - Bold Regulatory Affairs Specialist Society
- Denver Rocky Mountain Association Regulatory Affairs Society
Timeline
Research and Development Specialist
AlloSource
07.2016 - CurrentRead More
Quality Assurance Engineer
AlloSource
01.2015 - 07.2016Read More
Biologic Specialist
ALLOSOURCE, CENTENNIAL CO
09.2011 - 07.2015Read More
Certified Veterinary Technician
LITTLETON EQUINE MEDICAL CENTER
03.2008 - 07.2011Read More
Colorado State University
Bachelor of Science
Read More
Colorado Mountain College
Associate of Arts from Business Administration
Read More
Colorado Mountain College
Associate of Science from Veterinary Technology
Read More