[Remote] Clinical Product Surveillance Specialist

Note: The job is a remote job and is open to candidates in USA. Medline Industries, LP is a healthcare company, and they are seeking a Clinical Product Surveillance Specialist. This role involves investigating post-market complaints, providing clinical resource support, and ensuring compliance with safety regulations to advocate for patient safety and improve product efficacy.ResponsibilitiesIdentify and investigate domestic and international post-market complaints with a potential safety issue and escalate complaints for further investigations as neededEnsure adverse event reports (i.e. MDRs, ICSRs) are processed, prepared, and submitted to the FDA within regulation timelinesProcess FDA reportable post-market complaints and assist in coordinating international adverse event reporting with local health authorities or authorized representativesCollaborate with team members and act as a clinical resource for internal and external customersEnsure communications are created and issued to internal and external customers. Review customer responses for technical and clinical accuracy as related to Medline productsProvide clinical insight, evaluation, and resolution during post-market, risk management, and design development/modifications processes for new and existing Medline productsParticipate in the analysis of safety and risk data within areas of responsibility and identify actionable findings, trends, or product safety issues that require further investigationsAssess clinical, health, and safety risks during Health Hazard Evaluations, product recall or field action determinations, and acceptance of product as-isEnsure compliance with applicable post-market regulations for areas of responsibility and participate in regulatory audits, regulatory body communications, and/or additional information requests as applicableParticipate in process improvements and Corrective and Preventative Actions (CAPAs)Participate in the development and maintenance of processes/procedures associated with Adverse Event Reporting, Risk Management, and Standard Operating Procedures (SOPs) associated with Clinical Risk EvaluationFacilitate clinical safety meetings and conduct trainings related to post-market surveillance, clinical use, product risk, and SOP requirementsMaintain active Registered Nurse (RN) licensure and good standing with state or other governing licensure bodySkillsBachelor's Degree in Nursing (BSN) with at least 5 years of patient care experience OR a BSN with 4 years or less of patient care experience and 2 years of experience in a similar roleActively licensed as an RN to administer healthcare and in good standing with state or other governing licensure bodyKnowledge of quality improvement and patient safetyUnderstanding of clinical standards, processes, and workflowsFamiliarity with medical devices and pharmaceuticals related to patient safetyAbility to assess clinical outcomes, analyze data, and present findings to various audiencesProficiency in Microsoft Office (Outlook, Teams, Excel, Word, PowerPoint)Strong work ethic and proactive approach to responsibilitiesCustomer-focused with a results-oriented mindsetAbility to make sound judgments prioritizing patient safetyTeam player with analytical skills and a positive attitudeExperience in data analysis and reporting to identify trends and solutionsExperience working with cross-functional teams to solve complex problemsEffective time management skills to handle multiple projects and deadlinesAbility to work independently and escalate issues when necessaryProblem-solving skills to overcome obstacles and find successful solutionsAdvanced degree in nursing, medical or healthcare sciences, or other healthcare related fieldExperience within a Perioperative/OR, Critical Care (i.e. Emergency Department, ICU, Step-Down ICU, Cath Lab, etc.), or Wound Care/Management settingExperience in clinical, medical device, or pharmaceutical risk management and/or within the medical device or pharmaceutical industryExperience or working knowledge of government and industry standards and regulations for medical products (i.e. 21 CFR 803, 21 CFR 314, 21 USC 379aa, 21 CFR 7, ISO 13485, ISO 14971, etc.)BenefitsBonus and/or incentive eligibleHealth insuranceLife and disability401(k) contributionsPaid time off401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp for roles where employees work less than 30 hours per weekCompany OverviewMedline is the largest provider of medical-surgical products and supply chain solutions serving all points of care. It was founded in 1966, and is headquartered in Mundelein, Illinois, USA, with a workforce of 10001+ employees. Its website is http://www.medline.com/home.jsp.Company H1B SponsorshipMedline has a track record of offering H1B sponsorships, with 74 in 2026, 340 in 2025, 142 in 2024, 141 in 2023, 143 in 2022, 137 in 2021, 113 in 2020. Please note that this does not guarantee sponsorship for this specific role.