Neil Kelly
Sr. Director, Global Regulatory Affairs at Hologic, Inc.
- Role
- Sr Director, Global Regulatory Affairs at Hologic, Inc.
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Neil Kelly
I have roughly twenty years of Regulatory Affairs experience spanning across medical device, biologics, and IVDs. The majority of my career has been spent in medical device working with class I, class II and class devices. My responsibilities have included capital equipment, single-use disposables (SUD), mammography, as well as software as a medical device (SaMD). Submission experience includes pre-submissions, 510(k), IDE, as well as PMA. Geographies covered include US, EU (MDR), Canada, LATAM as well as APAC. My skills and knowledge are related to developing Regulatory strategy, submission planning and execution, inspections and audits. Throughout my career I\'ve demonstrated an ability to provide coaching, leadership, management and motivation in a team environment to successfully achieve company goals by improving process efficiencies, reducing risk factors and developing and maintaining robust regulatory documentation.
Experience
Sr Director, Global Regulatory Affairs
Jun 2025 — Present · Marlborough, MA, US
Education
Johnson & Wales University
B.A., Business Management/Operations
Assumption University
MBA, Business Administration, Management and Operations
Skills
- 510 K
- Technical File
- Iec 60601 3rd Edition
- Iso 13485
- Fda
- Medical Devices
- Iso 14971
- Regulatory Affairs
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