Applied Medical Technology, Inc. (AMT) · 1 month ago
Regulatory Affairs Specialist
Brecksville, OH
Full-time
Onsite
New Grad, Entry LevelApplied Medical Technology, Inc. (AMT) is a company specializing in enteral device product development and manufacturing. The Regulatory Affairs Specialist will be responsible for preparing submissions to regulatory agencies and ensuring compliance with domestic and international regulations.
Health CareManufacturingMedical Device
Responsibilities
Prepare and submit regulatory documentation, such as FDA 510(k) premarket notifications, to regulatory agencies, including FDA, Notified Bodies, and Authorized Representatives
Prepare, maintain, and submit, when necessary, European Medical Device Directive and European Medical Device Regulation compliant Technical Files
Create and/or modify regulatory procedures to remain in compliance with FDA, ISO, European, Canadian, and other standards
Work with the international department on various regulatory filings for product registration in different countries
Provides regulatory support for other projects as required
Updating appropriate personnel on new and revised processes and procedures
Process, execute, organize and archive various internal documentation related to Engineering and/or Quality Systems
Preparing change order documentation and routing it for final approval
Qualification
Required
Minimum of 2 year college degree
Ability to communicate across functions, professional levels and background
Intermediate to advanced knowledge of Microsoft Office Suite
Knowledge of modern business communication, office procedures and methods
Skill to use a personal computer and various software packages such as Microsoft Office Suite
Ability to establish priorities, work independently with minimal supervision, and facilitate teamwork
Must be able to effectively communicate with others; complete and understand complex situations, analysis of numbers; read, analyze and interpret written materials; work with team to meet and exceed company standards; ensure compliance with company policies; respond appropriately to feedback to make improvements; maintain positive working relationships; troubleshoot and solve problems
Must be able to communicate for hours at a time, use computer equipment
Persons in this position may be required to pass a drug, alcohol, and/or criminal background check
Preferred
Bachelor's Degree (or greater) preferred
Relevant work experience, preferably in the medical or legal field and/or other regulated industry
Previous experience creating and revising labels and DFUs preferred
Knowledge of European, ISO 13485 and FDA regulations preferred
Knowledge of international regulatory guidelines regarding GMP requirements is desirable
Benefits
AMT offers major medical, dental, and vision insurance at the first of the month following 30 days of service.
AMT offers several other voluntary benefits including hospital indemnity, critical illness, term life insurance & long term disability (company paid), among others.
AMT matches 100% of your contribution, up to 3% of your salary.
In addition to nine paid holidays, AMT provides employees with paid time off (determined by length of service), starting on day one.
Family-oriented, Positive Working Environment
Discretionary Yearly Raises
On-site Vending & Gym
Annual Employee Appreciation Picnic
Tuition Reimbursement
Employee Referral Bonus Program
Employee Assistance Program
Company
Applied Medical Technology, Inc. (AMT)
Applied Medical Technology, Inc.
Founded in 1986
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
George J. Picha
Founder and CEO
Recent News
Google Patent
2025-05-06
2025-02-16
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