SENIOR COMPLAINTS SPECIALIST

THE COMPANY:

Element Science, Inc. is a medical device and digital health company focused on developing solutions at the intersection of clinical-grade wearables, machine learning algorithms, and lifesaving therapies in order to address leading causes of death and hospitalization in patients with heart disease, primarily as they transition from the hospital-to-home. By putting the needs of patients and physicians first, our personalized digital devices, which are designed for function, comfort, and ease-of-use, aim to redefine the paradigm of care for these patients. Our first product, a wearable patch defibrillator, is initially targeted at treating the more than 500,000 patients in the US with an elevated temporary risk of potentially experiencing a lethal heart rhythm. Based in San Francisco, our funders include Third Rock Ventures, Google Ventures, Deerfield Healthcare, Qiming Venture Partners USA, Cormorant Asset Management, and Invus Opportunities.

SUMMARY OF ROLE:

The Senior Complaints Specialist is a key addition to the Quality Assurance team. This role will lead the complaint handling process, MDR reporting, and EU Vigilance processes. Collaborates with cross-functional teams to address customer concerns and improve product quality. If you have a proven track record of handling and managing those Quality System elements, we would love to talk to you.

RESPONSIBILITIES:

• Act as the complaint lead to oversee the complaint handling, MDR reporting, and EU Vigilance processes.
• Leads complaint activities and guides effective complaint analysis promptly.
• Responsible for oversight and training of Complaint Specialists, including assignment of complaint-related tasks.
• Lead MDR Committee for reportable events and completes Health Hazard Evaluation (HHE) and Health Risk Assessment (HRAs) in a timely manner.
• Coordinate the oversight of complaint-related tasks assigned to areas outside of the complaint group.
• Lead meetings with appropriate departments for specific customer complaint issues, determination, and resolution of root causes for complaints.
• Provide leadership and guidance when necessary to ensure issues are being addressed and escalated promptly.
• Provide analysis of complaint data/trends and identify potential corrective or preventive actions.
• Identify and implement efficiency and compliance improvements to the complaint management process.
• Responsible for ensuring complaint files are addressed and comply with regulatory requirements for complaint management.
• Other tasks as assigned by the management.

QUALIFICATIONS:

• Bachelor's degree in a scientific or engineering discipline, mechanical, electrical or software engineering preferred.
• 7+ years experience in the medical device industry with 4+ years experience in the complaint handling process.
• Previous experience with MDR Reporting via FDA portal.
• Knowledge of FDA 21 CFR 820,21 CFR 803, and ISO 13485.
• Experience working in the medical device industry, preferably Class III.
• Strong communication and organizational skills required.
• Accuracy, attention to detail, and thoroughness.
• Proficiency required with Microsoft applications.

BENEFITS:

Element Science offers a very competitive salary and benefits package including, but not limited to:

• Stock Options
• 90% employer-paid medical, dental, and vision insurance
• Company-paid Basic Life Insurance
• 401(k) retirement plan (Traditional and Roth)
• Competitive Paid Time Off
• Paid Holidays
• FSA (Flexible Spending Accounts)
• HSA (Health Savings Account)
• Employee Assistance Program through PEO

The salary for this exempt-level position will be based on experience and qualifications within an established pay range.

• Pay range: $100,000 - $115,000 + Annual Bonus