Senior Post Market Surveillance Consultant - Medical Device #0149

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 Senior Post Market Surveillance Consultant resource will be responsible for processing complaints and regulatory (MDR, Vigilance, other) reports to ensure that complaints are documented, reviewed, evaluated, investigated, and formally closed in a timely manner.

Key Responsibilities

• Responsible for evaluating and processing complaints received by a client.
• Support complaint receiving and handling (documentation, coordination, investigation, resolution, and closeout)
• Check accuracy of complaint files at various points in the process.
• Support with follow-up activities (e.g. additional information and product)
• Support complaint closure within Complaint Management System (CMS)
• Assess complaint events/files for reportability per client’s process and applicable regulations.
• Initiate Medical Device Reports (MDR) for FDA submissions
• Complete MDR/vigilance reports per client process and regulations.
• Regularly report to client management and stakeholders on the progress of Complaints and MDR.
• Interface directly with client’s internal and external customers and regulatory agencies as required.
• Additional items as required to support the project.

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.