- 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.
- 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.
- 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
- Pay range: $100,000 - $115,000 + Annual Bonus
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Sr. Complaints Specialist - Redwood City, United States - Element Science Inc
Description
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:
QUALIFICATIONS:
BENEFITS:
Element Science offers a very competitive salary and benefits package including, but not limited to:
The salary for this exempt-level position will be based on experience and qualifications within an established pay range.
Element Science is an Equal Opportunity Employer. All candidates will be evaluated on the basis of their qualifications for the job in question. We do not base our employment decision on an employee's or applicant's race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), political affiliation, military service, or other non-merit-based factors prohibited by local, state, or federal law.
In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.We are not able to sponsor individuals for employment visas for this job.At this time, we are unable to offer relocation assistance at Element Science.
