Cook Medical Post Market Regulatory Manager in bloomington, Indiana

Overview

The Post Market Regulatory Manager is primarily responsible for the oversight of assessing, evaluating, and adverse event reporting to Regulatory Authorities for the complaint handling process. Responsible to collaborate with other entities in gathering additional information, and managing day-to-day operations while providing leadership and direction to the team.

Responsibilities

• Manage and coordinate activities of assigned staff to support goals, objectives, and continuous improvement projects• Direct and oversee processing of complaints and adverse event reports• Prepare and communicate reports and metrics, related to complaint handling performance, to management, department staff and entities• Interface, communicate, and coordinate with regulatory agencies and entities on adverse events and inquiries.• Communicates and supports activities with complaint investigations and post market surveillance• Monitor the global regulatory developments of new regulations, policies, and guidance issued by regulatory authorities that may have impact to the department• Oversee department training and training plans• 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• Minimum of 3-5 years of leadership experience required• Minimum 2 years of experience with FDA and GMP regulations• Knowledge of medical device regulations (ISO 13485, 21CFR parts 803, 806, 820 and MEDDEV / EU MDR)

• 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

Requisition ID2018-5583

Job Location(s)Bloomington IN United States

Position TypeFull Time

CompanyCook Inc.

CategoryRegulatory Affairs