Post Market Surveillance Specialist

The Regulatory Affairs Specialist – Post Market Surveillance Specialist 2 will be involved in the development and generation of post market surveillance (PMS) plans and reports for Cook Vandergrift Inc. medical devices. In addition, will perform activities association with PMS, including Post Market Clinical Follow-Up (PMCF), and Clinical Evaluation Plans and Reports (CEPs, CERs). The Specialist 2 develops regulatory strategies, obtains and maintains approvals, and serves as a communication liaison between the Cook manufacturer and the Cook International Local Office / Cook Distributor and Notified Body.

• Maintain an excellent understanding of global medical device regulations for in relation to Post Market Surveillance (PMS), Summary of Safety and Clinical Performance (SSCP), 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 21CFR Part 820 and others as required.
• Serve as a liaison on regulatory issues between the Cook manufacturer and Cook Local Office and/or Cook Distributor and Notified Body.
• 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.
• Liase 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.
• Serve as a liaison on regulatory issues between the Cook manufacturer and Cook Local Office and/or Cook Distributor and Notified Body.

• Preparation of relevant information / responses for regulatory submissions, working with other members of the RA department.
• Preparation of Clinical Evaluation Plans and Clinical Evaluation Reports.
• Review & analysis of adverse event/complaint information as required.
• Ensures, in conjunction with Medical Affairs and other personnel, that the clinical requirements of the product are adequately addressed.
• Create, organize, and maintain technical documentation of manufactured devices.
• Provide support to currently marketed products as necessary including input on/creation of change requests, etc.
• Performs additional duties as assigned

• 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, SSCP, PMCF and CERs particularly in relation to the EU (MDD & MDR regulations) would be advantageous.

• 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.
• Computer experience required- Microsoft Office programs

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