Mary Fallon Email & Phone Number

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Boston, Massachusetts

Amherst, Ma

While in this position, I supported the lead professor by reinforcing lessons, answering student questions, and leading class discussions, as well as corresponded with students on a regular basis to ensure they have an understanding of the class material. An important aspect of this position included evaluating resumes and cover letters written by students aspiring to find educational employment opportunities.

Amherst, Ma

In this position, I built shell listings for hundreds of SKU’s on platforms including Amazon, Wayfair, and Walmart. After building the initial listings, I created the profiles for each new product SKU on Skubana for inventory management on various sites. In addition to these responsibilities, I connected with customers on a daily basis and determine the best way to resolve any issues they may have with their products.

Amherst, Ma

I was one of 13 co-managers, responsible for the running of a student-run cooperative business on campus. My responsibilities included hiring new co-managers for future semesters and running the catering sector of our business, along with working in the kitchen while on shift. I was also a member of the Board of Student Business, where representatives from each student-run business meet to discuss issues we may be facing, work to help our community through volunteer work, and plan events to draw more attention to cooperative businesses on campus.

Greater Boston Area

Greater Boston Area

At ALKU, I focused on providing high level, talented experts within the areas of quality and compliance, regulatory affairs, and validation serving Medical Device and Diagnostics nationwide. With an unmatched standard of excellence, I made it my mission to ensure that every client meets FDA standards and resolves any and all compliance issues. It was my duty to build upon the relationship between my clients and ALKU beyond the formalities of a contracted placement to reach a new level of partnership. Through these relationships and delivery of quality resources I had effectively driven success in Quality Assurance, Validation, Regulatory Affairs, and project management.Keywords/Specialties: Quality Compliance, Validation, Regulatory Affairs, Medial Devices, Diagnostics, Quality Engineering, Recruiter, FDA Rules & Regulations, Quality Assurance / Engineering, Recruiter, GMP/GCP/GLP/QS Audits, Quality Systems implementations, process improvement, SOP red-lining/creation, work instruction and procedures development, ISO 13485 implementations/upgrades, Batch Records Review, Complaint Handling, CAPA, Adverse Event, and MDR process improvements and remediation, DMR/DHF Remediation, Mock FDA Audits, MO/Supplier Audits, FDA regulatory submission preparation/review, Regulatory Compliance training, Regulatory Filings, 510(k) Submissions, LE Mark, PMA Submissions, NDA, IDE, IND, Regulatory Strategy, Technical Files, MVP Development, Process and Product Validation Computer Systems Validation (CSV)- (ERP, LIM, QS Software, Training Software, etc.), Equipment Validation, Facilities and Utilities Validation, IQ/OQ/PQ Protocol Development and Execution

Bachelor Of Business Administration - Bba, Finance, General, Senior

Activities and Societies: Member of the Commonwealth Honors College

Bachelor Of Business Administration - Bba, Business/Commerce, General, Junior

Activities and Societies: International Society