Director of Post Market Products

DEKA Research & Development
Manchester
Workplace: OnsiteFull timeFunction: Executive & General ManagementExperience: 10+ yearsEducation: bachelorsSkills: ["Leadership","Communication","Problem-solving","Regulatory","Risk management"]

Lead and oversee all post-market surveillance for a diverse medical device portfolio in a high-visibility, regulatory-driven environment. Set strategy for PMS, CAPAs, PMCF, PSUR, and MDR submissions; drive risk-based policies, cross-functional investigations, and regulatory audits; mentor a multidisciplinary team and interface with FDA and Notified Bodies to ensure patient safety and compliance.

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DEKA Research & Development
DEKA Research & Development
3 months ago

Director of Post Market Products

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Last checked: 6 hours agoStatus: Live

Job Summary

Lead and oversee all post-market surveillance for a diverse medical device portfolio in a high-visibility, regulatory-driven environment. Set strategy for PMS, CAPAs, PMCF, PSUR, and MDR submissions; drive risk-based policies, cross-functional investigations, and regulatory audits; mentor a multidisciplinary team and interface with FDA and Notified Bodies to ensure patient safety and compliance.
Location: Manchester
Workplace: Onsite
Employment Type: Full time
Job Function: Executive & General Management
Seniority: Director level

Key Responsibilities

  • •Develop, implement, and continuously improve the post market surveillance strategy across the medical device portfolio, ensuring alignment with FDA regulations, ISO 13485, EU MDR, CMDR, and other standards.
  • •Oversee complaint handling operations, including intake, investigation, trend analysis, and resolution in compliance with 21 CFR Part 803/820, EU MDR, and related regulations, ensuring timely MDR submissions.
  • •Coordinate cross-organizational failure analysis programs with contract manufacturers to identify root causes and drive CAPAs to closure.
  • •Direct development/maintenance of Post Market Surveillance Plans, PMCF plans, and PSURs per EU requirements.
  • •Lead signal detection, establish thresholds and trending methodologies to identify safety signals from complaints, MDRs, service data, and literature.
  • •Interface with FDA, Notified Bodies, and other authorities on post market matters including MDR submissions, Adverse Event Reporting, FSCAs, and recalls.
  • •Provide leadership to a multidisciplinary team of engineers and specialists, fostering high performance and professional development.
  • •Collaborate with Regulatory Affairs to meet post-market reporting obligations across all markets where products are sold.

Key Requirements

  • •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 leadership role
  • •Deep knowledge of FDA post market requirements including MDR (21 CFR Part 803) and QSR/ISO 13485, as well as CMDR and regulatory expectations
  • •Hands-on experience with EU MDR post-market obligations (PMS plans, PSURs, PMCF) and robust failure analysis capabilities
  • •Experience with ISO 13485 and/or MDSAP, audit experience (FDA inspections and Notified Body audits)
  • •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
  • •Excellent written and verbal communication, strong leadership, and data-driven decision making
  • •Ability to interface with regulatory agencies and cross-functional teams across markets
  • •Strong problem-solving and risk-management skills to drive CAPAs and continuous improvement
Experience:10+ yearsMedical deviceLife sciencesRegulatory
Education:Bachelor's
Skills:LeadershipCommunicationProblem-solvingRegulatoryRisk management
Certifications:RACCQE
Tech Stack:SalesforceMasterControlTrackWise

Company Brief

DEKA Research & Development
DEKA Research & Development is a private R&D and product development firm founded by Dean Kamen that designs and manufactures medical devices, mobility systems, energy and water solutions, and low-volume production prototypes for healthcare and industrial customers.
Industry: Medical Devices
Company Size: Large (251 to 1,000 employees)
Growth: Established Company
Headquarters: Manchester, United States
Founded: 1982
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