Senior Quality Compliance Specialist

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Senior Quality Compliance Specialist

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    Senior Quality Compliance Specialist
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Senior Quality Compliance Specialist:



  • Assess complaints (root cause analysis) and determine if an investigation is required and document rationale if investigation is not required.
  • Execute timely analysis and reporting of adverse events and complete communication within the global regulatory time frames.  Also monitor, trends and track the timeliness of investigations and closure.
  • Communicate directly with national and international competent authorities on complaint/AE related questions (examples: FDA, Health Canada, BfArM, TGA, MHRA, MHLW, etc.)
  • Communicate directly with notified body, internal/external customers, distributors, physicians, suppliers and manufacturers to ensure timely completion of activities related to complaint and failure investigations.
  • Analyze information obtained during complaint investigations and prioritize complaint investigations to ensure that they are processed in a timely manner.
  • Conduct meetings, track action items and prepare documents related to complaints, vigilance, health hazard evaluations, CAPA, post-market surveillance and recalls.
  • Generate and review data and documents for compliance with U.S. and international regulations and requirements (ISO 13485, 14971, etc.).
  • Ensure that Company’s records, procedures, specifications, policies etc. comply with Federal, international and corporate standards, or other external regulations and requirements
  • Create documentation and train departmental and corporate personnel on the complaint handling, adverse event/vigilance reporting requirements and monitor compliance.
  • Responsible for staying current on international regulations and incorporating any revision or changes needed into SOP’s, work instructions, etc.


  • Bachelor degree in biology, health sciences, engineering, nursing or other related discipline.
  • Must have a broad understanding of regulatory and compliance issues that drive the medical device industry, including those outside of the area of his/her expertise. 
  • Should have knowledge of quality system regulations, MDR reporting system and adverse event processes.
  • Must possess good verbal and written communication skills with an investigative mindset and critical analysis skills.
  • Working knowledge of Microsoft Office software (Word, Excel, PowerPoint, Outlook).
  • Minimum 3 years’ direct experience in adverse event/MDR compliance role.
  • Must have previous experience in complaint handling and adverse event reporting.
  • Experience working with a database is preferred



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