Director, Post Market Quality

The Director of Device Post-Market Quality is the global process owner for complaint handling, medical device reporting (MDR), EU and global Vigilance reporting, field corrections and removal actions and associated reporting, and post-market surveillance processes and trending.  Manages a team of Quality professionals including the Designated Complaint Handling Unit in Irvine, CA.  This position is highly visible with key collaborative relationships across functions and global locations including manufacturing sites and in-market reporting partners.

• Lead a team to execute operational activities within post-market quality.

• Collaborate cross-functionally with a team to develop processes and systems that contains at minimum the following elements (1) creation of the post-market surveillance plan for new pipeline of devices (2) defining roles and responsibilities in the execution of the post-market surveillance plan throughout the clinical/commercial lifecycle, (3) periodic reporting against planned activities and (4) adverse event and complaint monitoring, including regulatory reporting (e.g. FDA MDRs). 

• Establish robust trending and monitoring metrics and trigger appropriate actions to minimize product complaints and enhance the overall performance of current and future device portfolio. 

• Maintain robust regulatory compliance state for areas within the functional responsibilities of the role and presents processes to external auditors (e.g. FDA and Notified Bodies) and executive management. 

• Serve as global process owner and subject matter expert for device post-market surveillance processes.

• Head the Designated Complaint Handling Unit to ensure robust and timely complaint handling processes, investigations, and reporting.

• Engage in continuous improvement activities of future generations of Inari Medical devices by identifying opportunities and recommending improvements to design and development of upcoming devices with the use of post-market data.

• Work closely with Medical Affairs to evaluate clinical scenarios and probable causes of adverse events. 

• Continuously develop and coach managers and professionals within post-market quality team while ensuring a robust pipeline of talent in U.S. and globally. 

• Actively participate in industry associations, conferences and forums, remaining current on emerging/changes regulations/standards and industry trends.

• Perform other duties as assigned.

Requirements:

• Subject matter expert in the areas of product lifecycle management, complaint handling, risk management and post-market monitoring.

• Skilled oral and written communicator with an ability to identify problems, review-related information, develop and evaluate options, and implement solutions.

• Experience working in a matrixed organization, leading through influence across stakeholders (Research & Development, Manufacturing, Marketing). Expert knowledge of device and combination product regulations/standards including 21 CFR Part 820, Part 806, Part 803 and ISO13485, ISO14971, EU MDR requirements, as well as, other global regulatory reporting requirements (e.g. ANVISA, NMPA, PMDA).

• Knowledge of continuous improvement methodologies and practices such as Lean and Six Sigma. Prior experience communicating with regulators, including FDA and leading elements of front and backrooms during inspections and audits. 

• Expert knowledge of global device adverse event reporting requirements (MDR and Vigilance).

• Knowledgeable in field action/recall strategy, management, and reporting (e.g. 21 CFR 806). Experience with the monitoring and analysis of post-market data including reactive and proactive data sets.

• Experience with establishing and maintaining a relationship with Notified Bodies in the EU for both CE mark certification and MDR opinions. System-based thinking with ability to develop and implement new systems and continuously improve them.

• Experience with establishing, mentoring, and growing U.S. and global Designated Complaint Handling Units. 

• BA/BS degree in Engineering, Life Sciences, Legal/Regulatory, or related field.

• Minimum 10 years of relevant experience.

• Minimum 5 years’ leadership/management experience

Inari Medical offers competitive health and wealth benefits for our employees. The base pay range for this position is  $190,000 - $225,000. A range of factors, including location, skills, and experience, will be considered. Actual compensation may vary.

Inari Medical is an Equal Opportunity/Affirmative<