Manager, Post Market Surveillance

POSITION SUMMARY

This position must provide leadership and subject matter expertise in global complaint handling quality system requirements and regulations. This position will manage the following complaint handling processes: complaint initiation, preliminary complaint investigation, call center and investigator staffing / management and complaint handling training. This also includes process monitoring, trending and reporting. This position will work closely with cross-functional groups to ensure proper and timely processing of complaints and other support activities.

The individual for this position must be able to work well in a team environment, foster team building, proactively communicate task status, and operate with a high level of initiative, along with excellent verbal and written communication skills for effective communication with various levels of management. The individual must be comfortable working in a fast-paced and constantly changing environment.

MAIN DUTIES/RESPONSIBILITIES

• Manage the incoming complaint/product report process, the preliminary complaint investigation process and provide expertise global complaint handling requirements for finished medical devices.
• Lead a team of post market call center representatives and specialists (investigators) providing coaching, feedback and development.
• Manage staffing multiple shifts to ensure required coverage is met.
• Perform call handling and investigation activities as needed to support the team.
• Monitor and review incoming calls and documented complaints for completeness, accuracy and compliance.
• Deliver performance reporting on key quality processes and metrics to support compliance monitoring and continuous improvement initiatives.
• Perform, support, mentor, and coach team on medical device QMS requirements and best practices for achieving "best in class" performance and process throughput.
• Ensure that the quality and regulatory compliance is maintained in accordance with both Internal and external quality systems and standards.
• Recruit top candidates for post market surveillance positions and ensure new hires/contractors are properly trained.
• Manage incoming complaint and product reporting process for non-Inspire medical devices, Inspire clinical devices and non-medical software applications.
• Support medical device and vigilance reporting as requested along with returned product and complaint closure teams.
• Manage special projects along with product improvement processes at the direction of quality management.

QUALITY SYSTEM RESPONSIBILITIES

• Document product and therapy related field reports within the prescribed timelines and provide any necessary documents required to complete the investigation. Provide follow-up reporting as needed.
• Complete training requirements and competency confirmations as required for this position within the required timeline.
• Comply with applicable quality system procedures/policies and make suggestions for continuous process improvement.
• Ensure all direct reports maintain training records that comply with applicable quality system requirements.

QUALIFICATIONS

Educational Requirements:

Required

• Bachelor's degree in a technical or scientific field or
• Bachelor's degree in any discipline with a minimum of 8 years experience in implantable medical devices

Preferred

• Bachelor's degree in an engineering, nursing or other medical field.
• Master's degree in a technical or scientific field.

Required Experience:

• Minimum 5 - 10 years' experience in the medical device industry.
• Minimum 5 years' experience in managing teams with customer facing responsibilities.
• Demonstrated team leadership skills and ability to prioritize, execute and report on projects
• Extensive knowledge on complaint handing requirements for ISO, FDA and European Medical Device Regulations/QMS Requirements (e.g. ISO 13485; 21 CFR Part 820.198, 820)
• Effective relationship management, ability to network, support and influence across the entire organization.
• Experience supporting external regulatory audits
• Strong interpersonal and communication (both verbal and written) skills.
• Ability to facilitate teams and deliver presentations.
• Strong project and time management skills
• Ability to work on multiple tasks concurrently with changing priorities
• Proficient with of MS Word, Excel, Outlook and PowerPoint

Preferred:

• Experience with Class III active implantable medical devices
• Clinical experience in nursing, sleep or other medical discipline
• Front room experience supporting external regulatory audits
• Advanced computer skills with Excel reporting and SQL
• Internal auditor training or certification

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