Post Market Surveillance Supervisor
- Mexicali, B.C.
- Permanente
- Tiempo completo
- Supervisory and leadership role within the Regulatory Post Market Surveillance team
- Approve timecards and time off requests in alignment with team resource and budget requirements
- Conduct 1:1 meetings with direct reports to provide guidance, development, performance feedback and opportunities for growth
- Annual Performance reviews conducted for direct reports
- Manage complaint workload with team to required backlog goals
- Write, review, and file Medical Device Reports (MDRs) and Vigilance Reports as required.
- Prepare responses to Regulatory agency requests for additional information as required.
- Represent Regulatory Compliance at selected cross functional meetings
- Investigating complaints:
- Perform classification of complaints and escalate complaints that require additional review.
- Perform Failure Analysis investigation review and escalate complaints that require additional review.
- File Regulatory Reports as identified and required (including Adverse Event and Incident related reports)
- Evaluate documentation for completeness and consistency, and assign additional actions as necessary to close the complaint file.
- Approve MDR/MDVs, as required.
- Approve final complaint file for closure after all applicable actions are completed.
- Assist with customer escalations as needed
- Evaluate complaints for reporting requirements in accordance with company procedures and Regulatory requirements.
- Analyze and trend Complaint data to identify new issues or systemic discrepancies as necessary.
- Escalate complaints to the Quality or other designated organization when new failure modes are encountered.
- Participate in new hire training and continuous Regulatory Compliance training as required
- Participate in process improvement activities to continuously improve process effectiveness
- Represent Regulatory Compliance at selected cross functional meetings
- Execute on projects as required
- Assist in writing or revising department procedures
- Prioritize team's tasks and meet deadlines.
- Perform other duties as directed
English: 80% strong communication and writing
Experience: 5+ years of experience in medical device field, with experience in the following areas:
- Supervisory or Lead experience (or equivalent) role in a Medical Device company
- Strong working knowledge of Medical Device Complaint files and quality record documentation
- Strong working knowledge of Regulatory reporting requirements for Medical Devices (US FDA requirements, EU MDD requirements, etc.)
- Mentor direct reports in day to day functions and career development
- Demonstrate cross functional communication skills in person, by email and by phone
- Strong interpersonal and organizational skills
- Ability to interface cross-functionally with other groups
- Independent thinker, willing to present alternative conclusions or inferences
- Builds productive internal/external working relationships with all stakeholders
- Ability to maintain professionalism in all types of environments
- Strong verbal and written communication skills, proven ability to translate analytical
- Exhibit strong leadership skills
- Demonstrate strong written and verbal communication skills
- Strong computer skills (Excel, Word, PowerPoint, database)
- Efficient independent worker with ability to focus
- Attention to detail
- Ability to lead meetings or cross functional teams to come to resolution
- Demonstrate cross functional communication skills in email and in person
- Excellent organizational and analytical skills
- Ability to handle and manage workload independently
- Prioritize numerous activities in a rapid paced environment
- Contribute to team oriented tasks