Post Market Surveillance Supervisor

Descripción y detalle de las actividades
The Supervisor should have a strong understanding of World Wide regulatory reporting requirements for medical devices, complaint system and process requirements. A firm overall understanding of Quality System Regulations as they relate to other areas in Post Market Surveillance including CAPA and Field Actions is required. The Supervisor must demonstrate strong analytical ability required to perform thorough analysis needed to resolve or escalate complaints. A strong ability in leadership skills and strategies for providing guidance/feedback to direct reports is essential. In addition, strong project management skills and experience in continuous improvement methodologies are preferred.

Roles and Responsibilities:

This position has responsibility and authority for:
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 final complaint file for closure after all applicable actions are completed.

Experiencia y requisitos
Education: degree in engineering, life science, or equivalent
English: 90% 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.)

Skills: The following skills are required for this position:
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

Beneficios
Beneficios de acuerdo a la LFT
seguro de vida
bonos anuales
caja de ahorro
comedor
fondo de ahorro
transporte
uniforme
seguro de gastos médicos
plan de indexación
utilidades garantizadas
servicios médicos en planta
Seguro de gastos funerarios
Seguro dental
Acciones de la compañía
Becas educativas
Nutriológo
Clases de Yoga