Full-Stack Developer (Cloud Native) Job at Medline Industries, LP, Northfield, IL

ZEdxUWVjUGNjMlJIYWtJNWVjTVBmZi9kRWc9PQ==
  • Medline Industries, LP
  • Northfield, IL

Job Description

Primary Responsibilities Include

  • Support the business priorities, determine the requirements for completing and maintaining product submissions and regulatory filings for clearance/approval in assigned market(s).
  • Provides direct assistance with registering new and existing products supplied by Medline to the MEA region.
  • Liaison with internal departments (ie Legal, Marketing, Supply Chain, QA & Regulatory) and distributors to ensure registration.
  • Liaising and negotiating with foreign regulatory authorities.
  • Liaise with suppliers when needed to obtain documents needed for registration.
  • Gathering, reviewing, organizing, and assembling all regulatory-related information on registration instructions and regulations in various formats.
  • Complete forms and requests originating from foreign government agencies.
  • Provide an effective follow-up during the registration process to ensure the completion of the product registration.
  • Ensuring compliance with MOH regulations in the MEA region.
  • Proactively liaising with Distributors regarding new regulations to maintain regulatory changes.
  • Identify and communicate any potential for improvements in view of reducing time to market.

Minimum Job Requirements Include

  • A diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognized in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices, OR a minimum of 3 years’ experience in Quality and Regulatory Affairs Management in a Medical Device
  • Excellent knowledge of the ISO 13485; and product registration
  • Proven ability to work collaboratively across functional departments;
  • Understanding of the current Regulatory environment and demonstrating the ability to perform within.
  • Ability to evaluate information to determine compliance with standards, laws, and regulations
  • Excellent written and oral communication skills; fluency in English and Arabic are required.

Job Tags

Similar Jobs

Insight Recruitment

Senior Project Manager - Landscape Architecture Job at Insight Recruitment

 ...of an established design firm. Were looking for a licensed Landscape Architect whos eager to be part of building a practicefrom...  ...for the design, quality, timeliness, and billing of landscape architecture projects. You'll work closely with a team of talented designers... 

ITR Group

Vulnerability Management Governance Lead Job at ITR Group

 ...Opportunity available for a experienced leader to own a IT vulnerability governance program and shrink the organizations exposure to emerging...  ...activities: troubleshoot issues, escalate blockers, verify data accuracy, interpret metrics, and translate findings into action... 

Radon Medical Imaging

Operations Manager Job at Radon Medical Imaging

 ...Title: Operations Manager Department: Service Reporting to: Operations Manager Location: Rome, GA Radon Medical Imaging is a world-class distributor of industry leading radiology equipment, a trusted independent medical device service provider specializing... 

High End Hiring

Dental Surgical Assistant Job at High End Hiring

 ...Join our esteemed dental practice as a Dental Surgical Assistant, where you will play a crucial role in providing high-quality care to our patients. In this position, you will assist with a variety of dental surgical procedures, ensuring that everything runs smoothly... 

LHH

Administrative Assistant Job at LHH

 ...years of administrative or office support experience ~ Strong communication and organizational skills ~ Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint)~ Ability to multitask and maintain confidentiality ~ High school diploma required; associates...