Senior Post Market Surveillance Specialist

Dallas, Texas | Quality Assurance / Safety

Sr. Post Market Surveillance (PMS), Medical Device

 

Our medical device client is in the enviable position of experiencing growth and exciting change.  The client’s Quality & Regulatory organization is in the midst of evolution, upgrading to meet the demands of the changing landscape of regulations.  They are looking for someone with the experience needed to build a compliant PMS system to meet the demands of FDA and EU requirements. S/he will collaborate cross-functionally to collect, analyze and trend post market data then report on the performance and efficacy of the devices to management. 

 

The qualified candidate will report to the Dir. of RA, work closely with the Compliance Specialist, interact with Quality on Complaints and ensure data are tracked in a method concurrent to the needs of FDA and Notified Bodies.  This position will be centrally responsible for the development and corporate-wide implementation of Post Market Methodologies. 

 

Responsibilities:

  • Maintains compliance with all applicable standards and regulations as regards PMS building SOP’s, WI’s and templates as needed in the QS
  • Champions the importance of capturing data to support PMS, Clinical Follow-Up, Clinical Evaluation and other related reporting needs in support of complete, accurate and appropriate DHF and Risk Management files.
  • Provides oversight to Complaint processing ensuring compliance with applicable regulations and standards like ISO 13485:2016, 21 CFR Part 820, EU MDR’s, etc.
  • Proactively plans and completed PMS reports, partnering with SME’s from RA, CRA, Project Mgmt., Engineering, Quality, and Sales/Marketing
  • Uses accumulated data to perform statistical analyses of incidents and events that could impact the risk/benefit profile of the assessed devices
  • Builds the necessary training to keep the organization compliant with Post Market Surveillance demands; training Compliance, Complaints, and Quality
  • Designs and implements the Adverse Event program providing reports to regulatory agencies or authorities as required
  • Directly involved with NPD for the purpose of preparing tools, processes, resources and reporting needs for post-release activities
  • Uses data/findings to collaborate with the appropriate technical functions to identify opportunities for product improvement, including participation in engineering priorities
  • Supports internal/external audits and inspections

Requirements:

  1. BS in Engineering or other appropriate Technical discipline; MS preferred
  2. 5 or more years in Post Market/Complaint Handling
  3. Experience with US Class I & II, EU Class I, II(a), II(b) and III medical devices
  4. Can provide demonstrable experience in the definition, creation and implementation of PMS documentation
  5. Works independently, establishes priorities, meets deadlines
  6. Exceptional analytical and statistical analysis skills
  7. Orthopedic device experience highly valued
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