The Role
The Project Manager will oversee post market surveillance activities, ensuring compliance with regulations, managing risks, and facilitating cross-functional collaboration.
Summary Generated by Built In
DEKA has an immediate opening for a Project Manager, Post Market Products to support and coordinate post market surveillance and product quality activities in a dynamic medical device research and development environment. This high-visibility role carries significant direct impact on the safety, compliance, and continuous improvement of DEKA’s life-changing medical device portfolio. The Project Manager, Post Market Products will report to the Director of Post Market Products and will play a key role in executing the organization’s post market surveillance strategy and maintaining rigorous oversight of field performance across the product portfolio.
How you will make a difference as Project Manager, Post Market Products:
One hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home DEKA, where we are taking the same innovation and cutting-edge technology into the modern age.
Behind DEKA’s brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing. Here at DEKA, some of the most innovative and life-changing products of our time are created, and new ideas are always welcome and explored.
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.
- 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.
- Coordinate the preparation and maintenance of Post Market Surveillance Plans, Post Market Clinical Follow-Up (PMCF) plans, and Periodic Safety Update Reports (PSURs) in accordance with EU regulatory requirements.
- 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).
- Maintain positive and cooperative communication with co-workers, customers, contractors, and vendors.
- Perform other related duties as assigned under management supervision.
- 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.
One hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home DEKA, where we are taking the same innovation and cutting-edge technology into the modern age.
Behind DEKA’s brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing. Here at DEKA, some of the most innovative and life-changing products of our time are created, and new ideas are always welcome and explored.
Skills Required
- Bachelor's degree in a technical field (engineering, science, or related discipline)
- Minimum of 5 years of experience in the medical device or life sciences industry
- Demonstrated project management experience
- PMP certification or equivalent is a plus
- Proficiency with project management and collaboration tools
- Working knowledge of FDA post market requirements
- Familiarity with EU MDR post market obligations
- Experience working within a Quality Management System compliant with ISO 13485
- Strong data analysis and reporting skills
- Exceptional written and verbal communication skills
- Excellent problem-solving capabilities
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The Company
What We Do
DEKA is one of the leading research and development companies in the country and is the birthplace of some of the most innovative and life-changing products of our time. For over thirty years, DEKA Research & Development Corp. has made Manchester, New Hampshire home. Located about an hour from Boston, the beach, and the mountains, we are situated in the beautiful and historic Amoskeag Millyard buildings located in downtown Manchester. DEKA continues to be a place where no idea seems too big and where creativity and crazy cool gizmos reign supreme. The engineers, technicians, machinists, designers and all of the other folks who make up DEKA are some of the most creative and innovative professionals you could ever hope to meet. It's a place where one crazy idea can end up being the next greatest invention. At DEKA we embrace the spirit of innovation and constantly aim to turn the impossible into a reality. DEKA is filled with people who are driven to be among the best and brightest in their field of work. It’s a concentrated bunch of really smart thinkers, doers and problems solvers, who are driven to using innovative design solutions and state-of-the-art technology to improve lives. We all see endless possibilities in the power of technology to do good. Employees have the opportunity to work on diverse projects that have a positive, enduring impact on millions of people worldwide. We are growing! We're always seeking passionate individuals to join our growing team of evolved thinkers.
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