A Day In The Life Of Our Manager, Complaints and Post-Market - Perform a wide variety of activities to ensure compliance with applicable quality and regulatory requirements.
- Oversee day-to-day activities of the complaint handling team, ensuring complaints are handled promptly and accurately
- Work closely with Product Quality Engineering team to ensure that investigations and complaints are completed and closed out in a timely manner
- Review complaint files to ensure all complaint elements have been addressed and properly documented within the complaint file
- Manage adverse event reporting activities including decision rationale and reporting documentation.
- Submit adverse event reports to regulatory authorities
- Manage complaint metrics and analytics including trending and measure against statistical trend limits
- Schedule post market surveillance reviews and complete post market surveillance reports based on applicable regulatory requirements
- Coordinate with clinical, marketing, sales, regulatory, and R&D to obtain their respective post market surveillance information based on regulatory requirements
- Support risk file updates based on post market data such as complaint rates and new hazards
- Review customer inquiries and service reports for potential complaints
- Identify and escalate complaints for potential adverse event reporting decisions
- Perform complaint case final reviews for closure
- Manage complaint handling team activities and provide guidance as needed
- Review, revise and create SOPs (Standard Operating Procedures) and/or WIs (Work Instructions) related to complaint handling, adverse event reporting
- Own CAPA and/or Nonconformances pertaining to complaints and adverse event reporting.
- Prepare SOPs and WIs and gather data as needed to support ISO 13485:2016 clause 8.2.1 Feedback and for OUS regulatory requirements
- Assist in audits (internal and external). May also conduct internal audits as needed.
- Other QMS activities as assigned
About You - At minimum a BS degree in a technical field such as engineering, computer science, or a science related discipline. 5 years' experience with a degree or 9 years without a degree
- 3+ years of complaint-handling experience in the medical device industry.
- Ability to manage others, their work, and your own multiple competing priorities.
- Working knowledge of the entire complaint handling process from intake, investigation, closure, and reportability assessments.
- Strong Working knowledge of US FDA 21 CFR 820, 803, and 806 requirements
- Basic Working knowledge of OUS adverse event reporting requirements
- Basic Working knowledge of OUS post market surveillance requirements
- Working statistical knowledge as it pertains to trending Intermediate understanding of mechanical and software aspects of medical devices
#LI-Hybrid
Pay TransparencyThe Pay Range for this position is listed. Noah Medical offers a comprehensive benefits package including: competitive pay, health insurance, 401K and stock purchase plans, tuition reimbursement, paid time off plus holidays, and a flexible approach to work with remote, hybrid, field or office work schedules.
Actual pay will be adjusted based on an individual's skills, experience, education, and other job-related factors such as location as permitted by law. Total compensation may also include additional forms of incentives.California Pay Range
$141,000-$177,000 USD
Benefits & Perks (For Full Time Employees):- Competitive Salary
- Comprehensive health insurance including Medical, Dental and Vision + HSA and FSA options
- Equity & Bonus Program
- Life Insurance (company paid & supplemental) and Disability insurance
- Mental health support through medical insurance programs
- Legal and Pet Insurance
- 12+ paid holidays, Flexible Time Off + Sick Time
- Paid parental leave
- In-office snacks and beverages
- In-office lunch stipend
- Learning & Development Opportunities: On-demand online training and book reimbursement
- Team building and company organized social and celebration events
Noah Medical may offer remote, hybrid, or onsite work arrangements within the state of California depending on the specific team and/or role where applicable.
