Post Market Surveillance Specialist III
Posted:
Friday, 17 January 2025
Valid Thru:
Sunday, 16 February 2025
Index Requested on:
Indexed on:
Location:
Plano, TX, 75074, US
Industry:
Manufacturing - Other
Occupational Category:
17-2031.00 - Architecture and Engineering
Type of Employment: FULL_TIME
Inogen is hiring!
Description:
Job Description: Post Market Surveillance Specialist III
Job Summary:
The Post Market Surveillance Specialist III will play a critical role in ensuring the timely and compliant handling of product complaints related to our medical devices. You will be responsible for managing, investigating, and resolving complaints in accordance with FDA, European, and other global medical device regulations, and company policies. This role requires expertise in complaint management systems, technical problem-solving, and cross-functional collaboration to ensure both customer satisfaction and regulatory compliance.
Responsibilities:
Complaint Intake & Evaluation:
- Receive and assess incoming product complaints related to medical devices, ensuring proper categorization and timely acknowledgment of complaints in accordance with internal procedures and regulatory requirements.
Investigation & Root Cause Analysis:
- Conduct thorough investigations of product complaints, including gathering relevant information from internal and external sources, conducting interviews with appropriate individuals, performing root cause analysis, and identifying trends or recurring issues.
- Collaborate with R& D, manufacturing, and regulatory affairs teams as needed to resolve complex issues.
- Perform timely good faith efforts to receive complaint devices back from customers.
Adverse Event Reporting:
- Determine adverse event reportability per global medical device regulations and company procedures.
- Prepare and submit required initial and follow-up reports (e.g., MDRs, Vigilance Reports) in a timely and accurate manner.
- Respond to regulatory authority requests for additional information in a timely manner.
Customer Communication:
- Serve as a point of contact for internal and external customers regarding complaint resolution status.
- Provide timely updates and ensure all communications are documented accurately.
Complaint Trend Analysis & Reporting:
- Analyze complaint data for trends and patterns, generate and present periodic reports for quality data reviews, and recommend actions to improve product quality, customer satisfaction, and regulatory compliance.
- Support preparation of safety data and in Clinical Experience Reports, Post Market Surveillance Reports, and Product Safety Updates Reports.
Health Hazard Evaluations (HHEs):
- Facilitate the cross-functional completion of Health Hazard Evaluations.
- Ensure compliance with company procedures and applicable global medical device regulations.
- Participate in the completion of the Post-Market Surveillance data within HHEs.
Field Actions and Product Recalls:
- Manage and coordinate field actions, including product recalls, safety notifications, or product corrections related to complaints.
- Work cross-functionally with regulatory affairs, legal, and marketing teams to ensure the timely execution of field actions and proper communication to affected parties.
- Ensure all actions are compliant with applicable regulations and guidelines.
Process Improvements:
- Ensure compliance of Post Market Surveillance processes with international regulations and standards.
- Drive process enhancements to procedures considering compliance, effectiveness, and efficiency improvements.
Cross-Functional Collaboration:
- Work closely with Quality Assurance, Regulatory Affairs, Manufacturing, R& D, and other departments to investigate complaints, resolve product quality issues, and implement improvements.
Audit Participation:
- Responsible for front and back room internal and external audit participation regarding Post-Market Surveillance.
General:
- Comply with all company policies and procedures.
- Assist with any other duties as assigned.
Qualifications:
Education:
- Bachelor of Science degree, preferably in Engineering, Nursing or other science field.
Experience:
- Minimum of 4 years of experience in FDA and EU complaint handling/medical device reporting within the medical device industry required.
- Experience with facilitating Health Hazard Evaluations and Field Actions preferred but not required.
Technical Skills:
- Strong understanding of medical device product life cycle and regulatory requirements.
- Proficiency in complaint management systems, and root cause analysis techniques.
- Familiarity with data analysis tools and trend identification.
Personal Attributes:
- Strong verbal and written communication skills, with the ability to articulate complex technical issues clearly and effectively to cross-functional teams and regulatory bodies.
- Strong analytical and critical thinking skills, with the ability to resolve complex complaints and implement long-term solutions.
- High level of attention to detail and accuracy, particularly when documenting complaints, investigations, and regulatory reports.
Responsibilities:
Please review the job description.
Educational requirements:
Desired Skills:
Please see the job description for required or recommended skills.
Benefits:
Please see the job description for benefits.
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