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Manager/Director Regulatory Affairs

The Judge Group

This is a Full-time position in Las Vegas, NV posted March 2, 2021.

Location: Las Vegas, NV
Description: Our client is currently seeking a Manager/Director Regulatory Affairs in Las Vegas!

This job will have the following responsibilities:

  • The Director of Regulatory Affairs is responsible for leading the regulatory activities within the company with emphasis on regulatory strategy and preparation, review and submission of documents for product submissions to support commercialization of the Company’s products.  The Director of Regulatory Affairs must be able to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet all required legislation.  This position will also be responsible for building out the Company’s regulatory team which will include developing, mentoring and supervising regulatory professionals hired by the Company.    Ideal candidate has successful 510(k) and CE preparation with electro-mechanical software controlled medical devices.

Qualifications & Requirements:

  • At least five (5) years of recent experience in regulatory affairs, specifically within medical device industry. CT (Computed Tomography experience highly highly preferred)

    Must have experience filing 510K from start to finish (being involved in process and preparation of 510K); need to have done multiple

    •  Experience with FDA and worldwide software development/submission requirements.  Experience with IEC 60601 safety standards compliance.

    •        Demonstrated experience in multiple aspects of regulatory affairs, including; strategy creation, design control, cGMP/Quality Systems, and import/export requirements.

Contact: lberry@judge.com

This job and many more are available through The Judge Group. Find us on the web at www.judge.com