Director of 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

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Post Market Surveillance, Complaint Handling, Regulatory Compliance, Risk Management, Failure Analysis, CAPA, Medical Device Reporting, EU MDR, ISO 13485, ISO 14971, Leadership, Team Management, Audit Support, Signal Detection, Quality Management Systems, Technical Writing

Industry

Biotechnology Research

Description

DEKA Research and Development, on behalf of Millyard Advanced Technologies, located in Manchester, NH, is a dynamic, growing company, focused on the development of new technologies that span a diverse set of applications. At Millyard we are dedicated to using innovative design solutions and state-of-the-art technology to improve lives. We are filled with people who are driven to be among the very best in their respective fields. Consequently, the atmosphere is rewarding and intense. Millyard employees have the opportunity to work on projects that have a positive, enduring impact on millions of people worldwide. Millyard has an immediate opening for a Director of Post Market Products to lead and oversee all post market surveillance activities in a dynamic medical device research and development environment. This high-visibility leadership role carries significant direct impact on the safety, compliance, and continuous improvement of DEKA’s life-changing medical device portfolio. The Director of Post Market Products will report to senior leadership and will be instrumental in driving a culture of proactive risk management and rigorous post market oversight across the organization. How you will make a difference as Director of Post Market Products: Develop, implement, and continuously improve the post market surveillance (PMS) strategy across DEKA’s medical device portfolio, ensuring alignment with FDA regulations, ISO 13485, EU MDR, Canada’s SOR-98-282 (CMDR), and other applicable standards. Oversee and direct 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. Coordinate cross-organizational failure analysis programs, working with contract development and manufacturing organizations to identify root causes of field failures and drive corrective and preventive actions (CAPAs) to closure. Direct the development 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. Own and drive the signal detection process, establishing thresholds and trending methodologies to identify emerging safety signals from complaints, MDRs, service data, and literature. 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. Develop and maintain risk-based policies and processes for complaint handling operations to consistently achieve complaint quality objectives. Interface directly 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. Provide leadership and mentorship to a multidisciplinary team of complaint engineers, failure analysis engineers, and post market specialists. Collaborate with regulatory affairs to ensure post market reporting obligations are met across all markets in which Millyard products are commercialized. Develop and report post market performance metrics to senior leadership, providing clear and data-driven insights into product quality and patient safety. Support internal and external audits, including FDA inspections and Notified Body audits, as the subject matter expert for post market surveillance activities. Establish and maintain procedures and work instructions governing all 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; advanced degree preferred. Minimum of 10 years of experience in the medical device or life sciences industry, with at least 5 years in a post market surveillance, quality, or regulatory role with demonstrated success in a leadership capacity. Deep 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. Hands-on experience with EU MDR (Regulation (EU) 2017/745) post market obligations, including PMS plans, PSURs, and PMCF requirements. Demonstrated expertise in failure analysis methodologies (e.g., fault tree analysis, fishbone/Ishikawa, 8D) and the ability to lead cross-functional investigations through to effective CAPA. Strong working knowledge of risk management principles and practices in accordance with ISO 14971, including post-production risk management and benefit-risk analysis. Experience managing and operating within a Quality Management System compliant with ISO 13485 and/or MDSAP. Proven ability to interface with regulatory agencies, including direct experience supporting FDA inspections, and Notified Body audits related to post market activities. Exceptional written and verbal communication skills, with the ability to translate complex technical and regulatory content for diverse audiences. Strong leadership and team management skills, with a track record of building and developing high-performing quality teams. Excellent problem-solving capabilities and sound judgment in a fast-paced, dynamic R&D environment. RAC (Regulatory Affairs Certification) or CQE (Certified Quality Engineer) credential is a plus. Experience with complaint handling software (e.g., Salesforce, MasterControl, TrackWise) is a plus. About Millyard Advanced Technologies: https://millyardadvanced.com/ Located in the heart of the Regen Valley in Manchester, NH, our company aims to positively influence the healthcare landscape. Established 2019 Selected Partners Contract Designer: DEKA Research & Development Contract Manufacturer: Merrimack Manufacturing 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 to DEKA Research and Development, 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

Lead and oversee all post market surveillance activities to ensure the safety and compliance of the medical device portfolio. This includes managing complaint handling, failure analysis, and interfacing with regulatory agencies like the FDA and Notified Bodies.