Note: The job is a remote job and is open to candidates in USA. Axogen is a medical device and pharmaceutical company focused on restoring peripheral nerve function and improving patients’ quality of life. The Engineer II, Quality Complaint Management role manages the complaint system, serves as a principal complaint investigator, prepares regulatory reports, monitors system performance, and supports regulatory interactions and inspections.
Responsibilities
- Support investigator on complaints for all Axogen product lines
- Drafts and submits Health Hazard Evaluation Assessments (HHEAs), Field Alert Reports (FARs) and Medical Device Reports (MDRs) for review by Senior Management and submission to FDA or other regulatory bodies
- Supports interactions with FDA or other regulatory bodies regarding complaint response, status, and reportability determinations
- Drives and reports on the performance of the complaint management system, including but not limited to: complaint trending, on time closure, and timeliness of regulatory reporting
- Supports interactions between complaint reporters, Quality Engineering, Medical Affairs, and Regulatory Affairs to ensure complaints are reported and assessed in a timely way
- Coordinates timely Adverse Event determination and pharmacovigilance reporting to Medical Affairs
- Reports on complaint program status and issues to Senior Management
- Revises and approves controlled documents associated with the complaint system
- Trains personnel on the complaint system and improving training
- Supporting regulatory and notified body inspections as a subject matter expert
Skills
- Bachelor's degree in a scientific or medical discipline required
- At least 2 years' experience (five years' with a Master's degree or above) in the pharmaceutical or medical device industry required with a minimum of one year of experience working with medical device and/or pharmaceutical complaints
- Independent decision-making with high initiative
- Strong oral and written communication, collaboration, and interpersonal skills with those from diverse technical backgrounds
- Well-organized, with the ability to efficiently manage multiple, competing priorities
- Ability to assess and apply risk management principles per ISO 14971 and ICH Q9
- Working experience managing a complaint system compliant 21 CFR 211, 600, 820, 1271 and international standards is strongly preferred
Benefits
- Friendly, open, and fun team culture that values unique perspectives
- Company-wide dedication to profoundly impacting patients’ lives
- Comprehensive, high-quality benefits package effective on date of hire
- Educational assistance available for all employees
- Matching 401(k) retirement plan
- Paid holidays, including floating holidays, to be used at your discretion
- Employee Stock Purchase Plan
- Referral incentive program
- This position is eligible for an annual bonus
- Health insurance
- Dental insurance
- Vision insurance
- Matching 401K
- Paid Time Off
- 9 Paid Holidays + 3 Floating Holidays
- Dependent Care Flexible Spending Accounts
- Medical Flexible Spending Accounts
- Tuition Reimbursement
- Paid Parental Leave
- Paid Caregiver Leave
- Basic Life Insurance
- Supplemental Life Insurance
- Employee Stock Purchase Plan
- Disability Insurance
Company Overview
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