Post Market Surveillance & Clinical Specialist

Posting Date 1 month ago(9/22/2020 12:33 PM)
Requisition ID
2020-7908
Job Location(s)
Vandergrift PA United States
Travel
Less than 10%
Shift Type
First
Position Type
Full Time
Company
Cook Vandergrift
Category
Regulatory Affairs

Overview

The Post Market Surveillance & Clinical Specialist will be involved in the development and generation of post market surveillance (PMS) plans and reports for Cook Vandergrift Inc. medical devices. In addition, the Regulatory Affairs (RA) Specialist will perform activities association with PMS, including Post Market Clinical Follow-Up (PMCF), and Clinical Evaluation Plans and Reports (CEPs, CERs). 

Responsibilities

• Maintain an excellent understanding of global medical device regulations for in relation to Post Market Surveillance (PMS), Post Market Clinical Follow Up (PMCF), Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs) and responsibility for implementing regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, MDR 2017/745, FDA QSP 21CFR Part 820 and others as required
• Input and adherence to the scheduling and management of PMS plans and reports, PMCF plans and reports and clinical evaluations. Maintains appropriate regulatory records to demonstrate compliance with applicable regulations
• Liaise and advise other Cook functional units (Engineering, Divisions, Quality etc) of the relevant requirements for PMS and PMCF and ensures the outputs from the individual functional units meet the applicable regulatory requirements. Review and analysis of data for same
• Review & analysis of adverse event/complaint information as required

• Preparation of relevant information / responses for regulatory submissions, working with other members of the RA department
• Cover for Regulatory Reporting, this includes Adverse Event Reporting (MDR, Vigilance, etc), review of associated correspondence to applicable Regulatory bodies, Health Risk Assessments (HRA), Recall etc as required
• Preparation of Clinical Evaluation Plans and Clinical Evaluation Reports
• Ensure, in conjunction with Medical Affairs and other personnel, that the clinical requirements of the product are adequately addressed
• Conduct systematic, comprehensive searches of published medical literature; write clear and effective generation of search protocols and reports, examination of clinical evidence and provide input to risk assessment and product labeling as well as clinical / regulatory strategies
• Performs additional duties as assigned 

Qualifications

• Bachelor's degree in a technical discipline (Science/Engineering, Pharmacy, Nursing) or equivalent work experience
• 2 years experience in a regulated industry in a similar role
• Knowledge of regulations pertaining to PMS, PMCF and CERs particularly in relation to the EU (MDD & MDR regulations) would be advantageous

• Computer experience required with working knowledge of Microsoft office programs

• Knowledge of medical device quality standards/practices or similar regulated industry
• Good communication and inter-personal skills with ability to communicate clearly and concisely in both spoken and written form
• Medical device industry regulatory requirements knowledge required

 

Physical Requirements:

• Works under general office environmental conditions
• Sitting for extended periods; utilizes close visual acuity for working with computers, etc.

• Requires close visual acuity when working with computers, etc.
• Requires occasional early morning or late evening teleconferences
• International and domestic travel as required

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