JOB DESCRIPTION: Manager, Complaint Handling

Location: Neuspera Medical, Inc. headquarters in San Jose, CA

Reporting to: Director of Quality

JOB SNAPSHOT

Base Pay

Employment Type

Negotiable

Full-Time

Job Type

Manager

Education

4 Year Degree

Experience

Minimum 5 years

Manages Others

Yes

Industry

Medical Devices

Required Travel

Occasional

ABOUT NEUSPERA MEDICAL, INC.

Neuspera Medical, Inc. is an exciting early-stage medical device company with a uniquely positioned neuromodulation technology platform, headquartered in San Jose, CA.

Neuspera is committed to developing implantable medical device technology that will improve the lives of patients battling chronic illness. With the first intended indication for use as Urinary Urgency Incontinence (UUI), the platform technology is ultimately designed to deliver targeted bioelectronic medicine for a variety of conditions. Neuspera’s minimally invasive implants with external wearable transmitters offer the possibility for therapies to reach deeper, harder to access anatomical locations in the body.

WHY NEUSPERA?

Take the next step in your career and join Neuspera today to change lives through the products we help create. Here, you will contribute your talents to meaningful projects that impact the lives of patients around the world and develop as an individual by working directly with a team of seasoned experts and rising stars. Our values of accountability, respect, tenacity, results, and integrity are embedded in everything we do. No matter what your role may be, Neuspera strives to ensure all our employees are empowered and given the necessary tools to lead us in our relentless pursuit of success.

PRIMARY FUNCTION

Develop the workflow and manage the intake, documentation, and evaluation of customer complaints in accordance with FDA, ISO, and other regulatory requirements.

JOB DUTIES

• Review returned materials and coordinate disinfection process
• Conduct and coordinate complaint investigations with internal teams, including engineering, quality assurance, regulatory, and manufacturing
• Ensure timely submission of mandatory regulatory reports, such as Medical Device Reporting (MDR) and European Vigilance Reports
• Analyze trends and root causes to identify potential product or process improvements
• Establish and monitor performance metrics, ensuring adherence to key performance indicators (KPIs)
• Provide training on complaint handling procedures and regulatory requirements
• Collaborate with cross-functional team to resolve issues and improve customer satisfaction
• Maintain and improve the complaint management database/system
• Create and present reports and analyses for Complaint Meetings and Management Reviews

JOB REQUIREMENTS

• 5+ years managing complaints group in the medical device industry
• Basic understanding of the medical device industry including 21 CFR Part 820 and ISO 13485

QUALIFICATIONS AND EXPERIENCE

• Bachelor’s degree in Engineering, Science or similar field
• Results driven, collaborative team player capable of working well with others, as well as autonomously with little direction
• Ability to adapt to dynamic situations and adjust as we grow

COMPENSATION

Based on market data and other factors, the salary range for this position is $150,000 - $175,000. However, a salary higher or lower than this range may be appropriate for a candidate whose qualifications differ meaningfully from those listed in the job description.

WORK ENVIRONMENT

• Office and laboratory
• Some travel necessary
• Foster work culture of; Diversity and inclusion, honesty and integrity, accountability and teamwork, proactive communication focused on results that is based on facts and is respectful