Specialist,Regulatory Affairs

📁
Quality
📅
191CK Requisition #
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EDUCATION and/or EXPERIENCE:


  • BA/BS degree in engineering or life sciences

  • At least five years of progressive experience in domestic/international regulatory submissions, design control systems and/or regulatory compliance.

  • Experience with product registration requirements US, Canada, EU and other major international markets i.e. China, Australia, Brazil, Saudi Arabia, etc.

  • Experience in the preparation of 510(k) submissions

  • Experience with development and post market support of Class I and II Medical Devices


 


COMPETENCY/SKILL REQUIREMENTS:


  • This position assures company compliance to all pertinent United States FDA, state, and international regulatory requirements which are applicable to the design, manufacture and distribution of medical and diagnostic devices.

  • Knowledge of international quality and product standards for electro-mechanical equipment (e.g. ISO14971, ISO13485, EN60601, IEC62304, etc.)

  • Excellent written and oral communication

  • Strong project management and organizational skills.

  • Excellent verbal and written communication skills.

  • Strong analytical and problem solving skills.


SUPERVISORY RESPONSIBILITIES:

May supervise Returned Goods Technicians.  There would typically be less than 5 direct reports if applicable (Buffalo Grove facility).


 


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