Globus Medical
medical device
SeniorRegulatorySpecialist
“Senior Regulatory Specialist at Globus Medical. Skills: Regulatory Affairs, FDA Submissions, Medical Devices. Draft, submit and gain clearance for 510(k) submissions. Develop FDA submissions”
Industry & Context.
Evaluate regulatory impact of proposed product and process changes
Required to climb or and stoop, kneel, crouch or crawl, Required to regularly lift and/or move up to 10 pounds, Occasionally lift and/or move up to 25 pounds, Required to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus
What They're Looking For.
Must Have
5+ years of related experience in the medical device industry, Understanding of regulatory requirements throughout the product lifecycle, Solid understanding of regulatory terminology, pre-market submission types, and requirements, Able to evaluate regulatory impact of proposed product and process changes, Capable multi-tasking skills with the ability to project plan and meet deadlines, Result driven with a sense of responsibility, urgency and ability to perform under pressure
What You'll Do.
submit and gain clearance for 510(k) submissions
Develop FDA submissions
Partner with Product Development to prepare submissions
Prepare final 510(k) submissions
Submit 510(k) documents
Assist in completion of IDE and PMA submissions
Obtain and review clinical study data
Review Document Change Orders
Perform routine maintenance of approved PMAs
Determine Regulatory Pathway for new/changed products
Review and approve Regulatory Pathway Forms
Review and approve Note-to-File documentation
Understand company’s products
Develop relevant Regulatory SOPs
Ensure Compliance with governmental laws
How You'll Work.
Team & Collaboration
Partnering with researchers and educators; Working with personnel in various functional areas; Obtain timely submissions to FDA; Obtain and review clinical study data with Clinical Data Manager; Work with Clinical Affairs personnel; Building working relationships with internal teams
Process & Methodology
Project plan, Meet deadlines
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