Regulatory Affairs Coordinator

1 month ago
Requisition ID
2017-3213
Job Location(s)
Bloomington IN United States
Position Type
Full Time
Company
Cook Inc.
Category
Regulatory Affairs

Overview

The Regulatory Affairs Coordinator collaborates with the RA Specialists as needed to develop global regulatory strategies, and perform activities associated with obtaining and maintaining regulatory approval to commercialize Class I through III / IV medical devices in the selected target markets.

Responsibilities

• Completes projects as directed by RA Specialists
• Develops global regulatory strategies for Cook medical devices in collaboration with the Regulatory Scientist (as applicable)
• Advise other Cook functional units (engineering, marketing, etc.) of the requirements in each target market as directed by the RA Specialist
• Ensure the outputs from the individual functional units meet the applicable regulatory requirements
• Assists with preparation of regulatory submissions for specific target markets
• Collaborates with internal or external Cook regulatory team members
• Coordinates multiple projects at one time and provides regular reports to regulatory management
• Maintains an excellent understanding of global medical device regulations

• Collaborates with Regulatory Scientific Affairs on all high risk devices and new technologies
• Collaborates with the Clinical Functional Unit on projects requiring the collection of clinical data
• Provides support to currently marketed products as necessary
• Must work and interact effectively and professionally with and for others to achieve company goals
• Must strictly adhere to safety requirements
• Maintain regular and punctual attendance
• Must maintain company quality and quantity standards
• Must have effective oral and written communications throughout various levels of the global organization
• Ability to work in collaborative and independent work situations and environments with minimal supervision
• Ability to remain calm and receptive in fast paced situations

 

Qualifications

• Proficient in reading, writing and speaking the English language
• High School Diploma or GED required
• Associates degree preferred

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