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Director of Regulatory Affairs
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Our client is a well-established global brand in the area of medical device manufacturing with 11 facilities and over 3000 employees.
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Responsibilities
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| 1) Supervise the regulatory submissions group and clinical research
2) Develop regulatory strategies on new/modified medical devices
3) Ensure that appropriate change notifications and submission packages are prepared and submitted to the FDA International RA and CE Mark notified body on time
4) Handle submissions like 510ks, IDEs, PMAs, CE technical files, ROW dossiers, Australia inclusions, Canadian license applications and other international market applications |
Requirements
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| 1) 7 – 10 years of experience in regulatory affairs (submissions/clinical programs) particularly medical devices
2) IDE, clinical experience and 510(k) experience
3) Experience in communicating and working with FDA and other government agencies
4) PMA experience preferred
Applicants are encouraged to apply directly by going to: http://www.sterlinglifesciences.com/jobs/lifesciences-jobs-03237.html |
Additional Job Information
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