Director, Post Market Quality

$190,000 - $225,000/Yr

Inari Medical - Irvine, CA

Full-time - Senior

Irvine, CA

Miscellaneous Manufacturing

About the position

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.

Responsibilities

• Lead a team to execute operational activities within post-market quality.
• Collaborate cross-functionally to develop processes and systems for post-market surveillance.
• Establish robust trending and monitoring metrics to minimize product complaints.
• Maintain regulatory compliance and present processes to external auditors.
• Serve as global process owner and subject matter expert for post-market surveillance processes.
• Head the Designated Complaint Handling Unit for timely complaint handling and reporting.
• Engage in continuous improvement activities for future device generations.
• Work closely with Medical Affairs to evaluate clinical scenarios and adverse events.
• Continuously develop and coach managers and professionals within the team.
• Participate in industry associations and remain current on regulations and trends.

Requirements

• Subject matter expert in product lifecycle management, complaint handling, risk management, and post-market monitoring.
• Skilled oral and written communicator with problem-solving abilities.
• Experience in a matrixed organization, leading through influence across stakeholders.
• Expert knowledge of device and combination product regulations/standards including 21 CFR Part 820, Part 806, Part 803, ISO13485, ISO14971, EU MDR requirements, and global regulatory reporting requirements.
• Knowledge of continuous improvement methodologies such as Lean and Six Sigma.
• Experience communicating with regulators, including FDA, during inspections and audits.
• Expert knowledge of global device adverse event reporting requirements.
• Knowledgeable in field action/recall strategy, management, and reporting.
• Experience with establishing and maintaining relationships with Notified Bodies in the EU.
• Experience with establishing, mentoring, and growing 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.

Benefits

• Competitive health and wealth benefits
• Base pay range of $190,000 - $225,000
• Consideration of factors including location, skills, and experience for compensation