Sr. Regulatory Affairs Specialist

El Paso, TX

Posted: 03/12/2019 Employment Type: Contract Industry: ERT Job Number: 228829
Sr. Regulatory Affairs Specialist 
  • The Sr. Regulatory Affairs Specialist will  translate regulatory requirements into project/product requirements, prepare worldwide regulatory submissions, and negotiate their approval. In addition this professional will support pre/post-market compliance activities including product change notifications, and evaluating changes for regulatory impact. The Sr. Regulatory Affairs Specialist will possess Class I, II, III medical device experience and in-depth knowledge of FDA medical device regulations.
Required Skills:
  • A track record of developing and executing strategies for global regulatory approval.
  • 5+ years medical device industry experience with a minimum of 3 years regulatory role. Or advanced degree with 4-5 years industry experience. 
  • Working knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), EU Medical Devices Regulation (MDR 2017/745), and ISO 13485.
  • Class I, II, III medical device experience and in-depth knowledge of FDA medical device regulations.
  • Proven ability to maintain Regulatory Affairs product files and ensure compliance with regulatory requirements.
    Desired Skills:
    • Combination product, tissues of animal origin, and/or pharmaceutical experience.
    • Vascular access product experience. 
    • Proven ability to negotiate with regulatory authorities to resolve questions/issues that arise during submission review. 
    • Willingness participate on audit and field action teams as required. 
    Duration:  12+ Months PLEASE NOTE: 3RD PARTIES/SUBCONTRACTORS/SUBCONTRACT AGENCIES ARE NOT ELIGIBLE FOR THIS POSITION.   SUBCONTRACT AGENCIES NEED NOT APPLY.
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