Project Manager - Post Market Products at DEKA Research & Development

Manchester, New Hampshire, United States -

Full Time

Start Date

Immediate

Expiry Date

12 Sep, 26

Salary

0.0

Posted On

14 Jun, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Post Market Surveillance, Complaint Handling, Project Management, Regulatory Compliance, Risk Management, Data Analysis, Cross-functional Leadership, Medical Device Reporting, CAPA Management, Quality Management Systems, EU MDR, FDA Regulations, ISO 13485, ISO 14971, Technical Writing, Stakeholder Management

Industry

Biotechnology Research

Description

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: 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. Skills needed to be successful: 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. About DEKA: 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.

Responsibilities

Manage the planning and execution of post market surveillance activities and complaint handling for a medical device portfolio. Coordinate cross-functional teams to ensure regulatory compliance and the timely closure of CAPAs and MDR submissions.