Shea Whalen
Senior Staffing Consultant
- Role
- Senior Staffing Consultant at Beacon Hill
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Shea Whalen
Specialty Areas of Recruiting: Quality Compliance, Validation, Regulatory Affairs, Medial Devices, Biotechnology, Pharmaceuticals, 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
Experience
Senior Staffing Consultant
Jul 2025 — Present · Boston, MA, US
Education
University of New Hampshire
Bachelor’s Degree, Business Administration and Management, Finance
2015 — 2018
Clark University
Business Administration and Management, General
2014 — 2015
Skills
- Powerpoint
- Microsoft Excel
- Microsoft Office
- Leadership
- Public Speaking
- Project Management
- Management
- Microsoft Word
- Strategic Planning
- Customer Service
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