Risevoic
Post Market Surveillance Specialist
Company : Cook Medical
Location : Vandergrift, PA, 15690
Job Type : Full Time
Date Posted : 11 January 2026
Overview
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.
Responsibilities
• 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
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, 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
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Frequently asked questions
In Vandergrift, certifications like RAC (Regulatory Affairs Certification) and training on ISO 13485 or MDR regulations enhance a Post Market Surveillance Specialist’s credentials, reflecting expertise in EU and FDA compliance crucial for local medical device regulatory roles.
Cook Medical's Vandergrift location experiences moderate competition for post market surveillance positions, given its specialized nature. Candidates with strong regulatory knowledge in medical devices and familiarity with both FDA and EU standards stand out significantly.
Daily tasks include analyzing post market data, coordinating clinical evaluation reports, liaising with regulatory bodies, and ensuring compliance with international medical device standards, requiring a blend of technical scrutiny and cross-functional communication.
Professionals often advance into roles like Regulatory Affairs Manager, Clinical Affairs Lead, or Quality Assurance Director, leveraging their expertise in surveillance strategies to influence product lifecycle and regulatory compliance at a higher organizational level.
While both roles focus on monitoring, a Post Market Surveillance Specialist zeroes in on medical device safety and regulatory compliance post-launch, whereas a Surveillance Specialist may have broader tracking duties across various sectors, making the former more regulation-centric.
At Cook Medical, this specialist acts as a vital link between manufacturing, distributors, and notified bodies, managing global compliance intricacies with in-depth involvement in clinical evaluations, which may be more integrated than in firms with decentralized regulatory functions.
Salaries typically range between $70,000 and $90,000 annually in Vandergrift for this role, reflecting specialized regulatory expertise in medical devices, with variations depending on experience, education, and specific company benefits.
Challenges include staying updated with evolving FDA and EU regulations, managing cross-border communication with notified bodies, and integrating clinical data from diverse sources, which demands meticulous organizational and analytical skills.
Cook Medical offers exposure to cutting-edge medical devices, a collaborative environment linking engineering and regulatory teams, and opportunities to influence global compliance strategies, all within a community-focused setting in Vandergrift.
Proficiency in EU MDR and FDA 21 CFR Part 820 is critical, as it ensures compliance with stringent regulatory frameworks governing device safety and performance, directly impacting the quality and acceptance of medical products at Cook Medical.