Mary Mellows
- Role
- Principal Regulatory Specialist at Hologic, Inc.
- Location
- Branford, CT, US
- LinkedIn followers
- 500 followers
About Mary Mellows
20 years of significant experience in medical device, regulatory affairs. Responsible…
Experience
Principal Regulatory Specialist
Jul 2021 — Present
Regulatory responsibility over FDA Class I, II (510(k) clearance) and European Union (EU) Class I, IIa, IIb and breast biopsy marker product lines. • Create, submit, field inquiries, and maintain 510(k) submissions, MDR compliant Technical Documents, regulatory strategies, and change control assessments. • Contribute to project teams as the regulatory subject matter expert for both new product development and sustaining projects and initiatives. • Evaluate advertising and promotional materials to align with substantiated claims for the product. • Support audits - internal as well as FDA, Notified Body and regional audits. • Key contributor to Health Hazard Evaluations, Field Actions, Risk Management processes, procedures, and practices.
Skills
- Software Documentation
- Capa
- Engineering
- Product Lifecycle Management
- Quality System
- Gmp
- Design Control
- Fda
- Completion of Lean Six Sigma Training (March 2012)
- Regulatory Requirements
- Medical Devices
- Blackboard
- Sap
- Iso 13485
- Cross-Functional Team Leadership
- Six Sigma
- Strategy
- Windows; Microsoft Word, Excel, Powerpoint, Project, and Outlook
- Agile Plm
- Validation
- Regulatory Affairs
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