Project Manager - Post Market Products

How you will make a difference as Project Manager, Post Market Products:

• Manage the planning, scheduling, and execution of post market surveillance (PMS) activities across DEKA medical device portfolio, ensuring alignment with FDA regulations, ISO 13485, EU MDR, Canada’s SOR-98-282 (CMDR), and other applicable standards.
• Develop and maintain detailed project plans, timelines, and dashboards to track the status of complaint investigations, CAPA closure, MDR submissions, and other post market deliverables, providing regular status updates to the Director of Post Market Products.
• Career Development
• Coordinate complaint handling operations, including intake, investigation, trend analysis, and resolution in compliance with 21 CFR Part 803 and 820, EU MDR, and other applicable regulations, ensuring timely and accurate Medical Device Reporting (MDR) submissions.
• Identify, document, and actively manage project risks and issues, escalating blockers and proposing mitigation strategies to keep post market activities on schedule and in compliance.
• Facilitate cross-functional meetings and drive accountability across engineering, quality, manufacturing, and regulatory teams to ensure failure analysis investigations and CAPAs progress to closure on time.
• Contribute to the signal detection process by monitoring complaints, MDRs, service data, and literature against established thresholds and trending methodologies to identify emerging safety signals.
• Oversee the investigation, documentation, and reporting of product complaints and regulatory reportable events, including failure mode analysis and post market surveillance trend reporting per applicable procedures.
• Support interactions with FDA, Notified Bodies, Competent Authorities, and other regulatory agencies on post market matters, including MDR submissions, Adverse Event Reporting, field safety corrective actions (FSCAs), and recall activities.
• Collaborate with regulatory affairs to ensure post market reporting obligations are met across all markets in which Millyard products are commercialized.
• Develop and maintain post market performance dashboards and metric reports, providing clear and data-driven insights into product quality and patient safety for review by senior leadership.
• Support internal and external audits, including FDA inspections and Notified Body audits, as a subject matter contributor for post market surveillance activities.
• Author and maintain procedures and work instructions governing post market quality activities, ensuring alignment with the Millyard Quality Management System (QMS).

Requirements:

• Bachelor’s degree in a technical field (engineering, science, or related discipline) required.
• Minimum of 5 years of experience in the medical device or life sciences industry, with demonstrated experience in post market surveillance, complaint handling, quality, or regulatory affairs.
• Demonstrated project management experience, including the ability to develop and maintain project plans, manage competing priorities across multiple workstreams, track deliverables against regulatory deadlines, and communicate status effectively to stakeholders; PMP certification or equivalent is a plus.
• Proven ability to facilitate cross-functional teams, drive accountability without direct authority, and manage competing stakeholder priorities in a fast-paced environment.
• Proficiency with project management and collaboration tools such as Microsoft Project, Jira, Smartsheet, or equivalent; experience with complaint handling software (e.g., Salesforce, MasterControl, TrackWise) is a plus.
• Working knowledge of FDA post market requirements, including Medical Device Reporting (MDR) regulations (21 CFR Part 803), Quality System Regulation (21 CFR Part 820) / QMSR, Canada’s Medical Devices Regulations SOR-98-282 (CMDR), and Field Safety Corrective Actions.
• Familiarity with EU MDR (Regulation (EU) 2017/745) post market obligations, including PMS plans, PSURs, and PMCF requirements.
• Working knowledge of risk management principles and practices in accordance with ISO 14971, including post-production risk management and benefit-risk analysis.
• Experience working within a Quality Management System compliant with ISO 13485 and/or MDSAP.
• Strong data analysis and reporting skills, with the ability to synthesize post market data into clear metrics, trend reports, and executive summaries.
• Exceptional written and verbal communication skills, with the ability to convey technical and regulatory content clearly and accurately to diverse audiences.
• Excellent problem-solving capabilities and sound judgment in a dynamic R&D environment.