Kyle Hooper

* ***** *****, *******, ** *****

acxs0w@r.postjobfree.com

845-***-****

Background:

Well-rounded individual with the ability to efficiently complete assignments quickly and accurately. Understands the importance of an open channel of communication cross-functionally to optimize the result of each project.

Education:

St. Thomas Aquinas College, Sparkill, NY

Master of Business Administration with Distinction, Marketing St. Thomas Aquinas College, Sparkill, NY

Bachelor of Science in Biology

Experience:

Collagen Matrix, Inc., Oakland, NJ: 9/15 - Present Regulatory Affairs Associate

- Prepare and submit regulatory documentation for registrations and change notifications to applicable notified bodies (Health Canada, FDA, EU and additional countries as well)

- Track and provide responses for notified bodies regarding submissions and licensing

- Support external requests for distributors which includes: Financial Estimates/Billing, Letter of Authorization, Power of Attorney, Affidavit, Declaration/Certificate to Foreign Government, Flow Charts and more

- Manage distributors and communicate with customers to ensure deadlines are met

- Initiate and track standards: ASTM, CFR and ISO BS EN

- Manage and collaborate with distributors, Marketing, Quality Assurance and Materials Management to initiate and approve labeling (IFU, box design and labels)

- Author Regulatory Status Determination’s for notified bodies

- Compose post-market surveillance reports (sales, complaints, corrective actions, MAUDE Database, customer feedback and clinical studies)

- Effectively work cross-functionally with other departments (Marketing, R&D, QA, QC and Manufacturing)

Collagen Matrix, Inc., Oakland, NJ: 12/14 - 9/15

Product Line Lead

- Supervised a production line of 7 technicians to ensure deadlines were met

- Business-to-business sales experience by maintaining relationships with vendors

- Monitored progress for supply chain planning and forecasting product orders

- Optimized shelf-life expectancy to meet distributors product demand

- Understood lot control and shelf-life management

- Presented quarterly and annual reports to upper management

- Managed validation lots to launch new product lines for clinical trials

- Coordinated with management and employees to improve production

- Work cross-functionally with other departments (Marketing, R&D, QA, QC and Manufacturing)

Collagen Matrix, Inc., Oakland, NJ: 3/14 - 12/14

Manufacturing Technical Administrator

- Supported manufacturing operations by preparing, revising and organizing documents

- Authored/revised standard operating procedures and batch records

- Opened engineer change orders and tracked approval steps

- Trained the required audience on documentation changes or updates

- Wrote process deviations

- Organized product validations files, equipment qualifications and environmental files

- Supported organization of corrective action report and deviations

- Work cross-functionally with other departments (Marketing, R&D, QA, QC and Manufacturing)

Collagen Matrix, Inc., Oakland, NJ: 3/13 - 3/14

Senior Manufacturing Technician

- Engineered matrices for tissue and organ regeneration

- Followed GMP and FDA regulations

- Took inventory and assigned lot numbers

- Involved in several internal equipment & environmental audits St. Thomas Aquinas College, Sparkill, NY: 9/11 - 5/12 Lab Assistant

Airmont Animal Hospital, Suffern, NY: 3/09 - 11/12 Veterinarian Assistant

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