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Director of Regulatory Affairs

  • LocationSchaumburg, IL 60173 - United States
  • Work TypeFull time
  • Positions1 Position
  • Published At:4 months ago
  • Job no: 42324
  • Category: Regulatory Affairs

Job Description

Our client, a leading medical device company, is currently recruiting a Director of Regulatory Affairs who will infuse the Regulatory Affairs Team with their talent, energy and leadership skills. This is an exceptional opportunity to join a corporate culture that is known for its innovative and growth-oriented vision. Responsibilities include:

1) Provide leadership for the regulatory affairs function at all company facilities

2) Ensure compliance with international GMPs, and US FDA regulations in all countries of manufacture and exportation

3) Serve as the official contact with FDA and related regulatory authorities at the federal, state local and international level

4) Work with executive management and aid in the determination of extraordinary matters

5) Ensure timely regulatory filings for the company 

6) Serve as consultant and advisor for new products and facilitate the timely introduction of safe and effective new products

7) Ensure international market growth by providing the technical, quality and regulatory documents that are required to register products

8) Monitor the effectiveness of the production and business processes that impact customer satisfaction to develop, lead and execute corporate strategy aimed at maximizing the results of those processes and to report progress to the corporate officers globally

9) Educate corporately on areas of responsibility as appropriate

10) Hire, train, motivate, evaluate and develop direct and indirect reports for optimum performance and compliance

11) Evaluate department structure for maximum efficiency

12) Provide as-needed, guidance to parent company subsidiaries regarding regulatory issues

13) Perform other duties as assigned

Critical Requirements

1) A university degree is required. Although all candidates are welcome and encouraged to apply, preference will be given to those with degrees in a relevant field

2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)

3) Recent experience in the medical device industry is strongly preferred

4) Preference will be given to candidates with recent experience in regulatory affairs management

For the right leader, this is a wonderfully rewarding role with tremendous growth prospects. If you are qualified and think you're a strong fit for this role, please apply ASAP. We thank all applicants, but only candidates who meet our client's criteria will be contacted.

Compensation and Other Details

Base Salary: Highly competitive package, commensurate with experience

  • Published on 04 Aug 2022, 12:39 PM