What are the responsibilities and job description for the Senior Post Market Surveillance Specialist position at Cook Medical?
Overview
The Senior Post Market Surveillance Specialist is responsible for supporting the reporting process, assuring compliance with national and international regulations. Provides high level support and serves as a subject matter expert for Ensure Post Market Surveillance (PMS) plans and reports. Ensure adherence to applicable regulations, standards, and established procedures. Partners with other departments, facilities, and clinical professionals from a technical and functional perspective. Responds to inquiries and questions and liaises with fellow staff members as needed for responses.
Responsibilities
The Senior Post Market Surveillance Specialist is responsible for supporting the reporting process, assuring compliance with national and international regulations. Provides high level support and serves as a subject matter expert for Ensure Post Market Surveillance (PMS) plans and reports. Ensure adherence to applicable regulations, standards, and established procedures. Partners with other departments, facilities, and clinical professionals from a technical and functional perspective. Responds to inquiries and questions and liaises with fellow staff members as needed for responses.
Responsibilities
- Acts as a mentor and provides guidance to fellow staff members related to PMS plans and reports.
- Acts as a go to resource for staff members on complex reporting.
- Exercise’s judgment in selecting methods and techniques for evaluation and presentation of data.
- Applies knowledge of global regulatory medical device requirements in order to support decisions for reporting within regulatory time frames.
- Assists management with work flow specialist assignments.
- Assists with various projects as assigned by a direct supervisor.
- Collaborate with functional teams to collect, review, and analyze data for the Post Market Surveillance (PMS) process.
- Schedule and facilitate Post Market Surveillance meetings to discuss plans and reports.
- Collect, review, and edit Post Market Surveillance data for PMS plans, reports and Clinical Evaluation Reports.
- Generate plans and reports to ensure compliance with evolving regulations.
- Monitor, track, and communicate project progress to leadership
- Must be able to proactively prioritize workload
- Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.
- Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.
- Bachelor’s degree in a related field preferred; Associates degree in Regulatory Affairs; or experience of such kind and amount as to provide a comparable background.
- Minimum 5 years’ experience in the field of Regulatory Affairs in the medical device industry preferred.
- Must be proficient with Microsoft Word, Excel and PowerPoint.
- Works under general office environment conditions
- Utilizes close visual acuity for working with computers and equipment
- Frequently required to sit, stand, walk, and communicate
- Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA
