Regulatory Reporting Manager

1 month ago
Requisition ID
2017-2712
Job Location(s)
Bloomington IN United States
Position Type
Full Time
Company
Cook Inc.
Category
Regulatory Affairs

Overview

The Regulatory Reporting Manager directs and oversees activities associated with product complaints, Adverse Event Reporting, and Field Actions(i.e. Corrections, Removals, Field Safety Notices, etc.) to insure compliance with FDA regulations, Medical Device Directive (MDD), ISO 13485 and Canadian Medical Device Regulations (CMDR). They will manage day-to-day operations and provide leadership and direction to the functional team.

Responsibilities

• Direct and oversee processing of complaints and adverse event reports
• Communicate to management complaints and adverse event reports
• Direct and oversee all activities related to corrections and removals, field safety corrective actions, including associated documentation
•Communicate with FDA and regulatory bodies regarding corrections and removals and field safety corrective actions
• Ensure latest versions of FDA, MDD, ISO13485 and CMD Rrequirements are reviewed for any changes related to Complaints, Adverse Event Reports and field actions. Implement as necessary.
• Make recommendations for staff and equipment and have significant input into personnel matters
• Implement policies, programs and directives of senior management
• Interview, select and approve all training for employees
• Foster and maintain a workplace culture respectful and supportive of individual differences

• Must work and interact effectively and professionally with and for others throughout various levels of the global organization
• Must strictly adhere to safety requirements
• Maintain regular and punctual attendance
• Must maintain company quality and quantity standards
• Must have effective oral, written and presentation communication skills
• Ability to remain calm and receptive in fast paced situations
• Must have excellent analytical and problem solving skills

 

Qualifications

• Bachelor of Science degree in related area or 3 years of experience in a quality or regulatory function
• Minimum 2 years of experience with FDA and GMP regulations
• Demonstrates knowledge of medical device regulation (ISO 13485, 21CFR parts 803, 806, 820 and MEDDEV)

• Proficiency in the Microsoft Office suite of products (Word, Excel, Powerpoint and Outlook) is required
• Strong organizational skills
• Critical thinking and attention to detail required
• Excellent verbal communication skills and technical writing

• Must be able to perform the essential functions of the job, with or without reasonable accommodations

• Work is performed in a normal office environment with majority of day spent sitting and moving around the department

• Requires occasional early morning or evening teleconferences

• Must be willing and able to travel as necessary

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