Post Market Surveillance SME - Medical Device #6887

About ECI ECI's mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges, and we take pride in providing them transformative solutions with distinctive, sustainable and long-term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry. About the Role The Post Market Surveillance (SME) is responsible for monitoring, evaluating, and reporting on the safety, performance, and regulatory compliance of medical devices after they have been released to the market. This role ensures that real-world product data is collected, analyzed, and used to identify potential risks, drive continuous improvement, and maintain compliance with global regulatory requirements. Key Responsibilities Lead and support post-market surveillance activities for medical devices. Analyze complaint, adverse event, and field performance data to identify trends and potential safety concerns. Develop and maintain PMS plans, PMS reports, and Post-Market Clinical Follow-up (PMCF) documentation. Ensure compliance with global regulations, including

FDA, EU MDR, ISO

13485, and other applicable standards. Conduct risk assessments and collaborate with cross-functional teams to update risk management files. Support investigations related to product complaints, nonconformances, CAPAs, recalls, and field corrective actions. Prepare regulatory submissions and responses related to post-market activities. Present findings and recommendations to management, regulatory authorities, and external auditors. Partner with Clinical, Quality, Regulatory Affairs, R&D, and Manufacturing teams to drive product improvements. What We Look For Bachelor's degree in engineering, Life Sciences, Quality, Regulatory Affairs, or related field; advanced degree preferred. 5+ years of experience in Medical Device Quality, Regulatory Affairs, Clinical Affairs, or Post Market Surveillance. Strong knowledge of FDA Quality System Regulations (21 CFR Part 820), EU

MDR, ISO 13485, ISO

14971, and vigilance reporting requirements. Experience with complaint handling, risk management, CAPA, and adverse event reporting. Familiarity with active implantable and/or Class II/III medical devices preferred. Strong analytical, technical writing, and problem-solving skills. Ability to interpret complex clinical and technical data and communicate findings effectively. Regulatory and quality systems expertise Risk-based decision making Data analysis and trend identification Technical documentation and report writing Cross-functional collaboration and leadership Attention to detail and compliance focus Effective communication and presentation skills ECI is an equal opportunity employer. All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship now or in the future. At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity.