Medical Device Compliance Manager

US-MA-Cambridge

Overview

InterSystems develops software that serves as the information engine powering some of the healthcare industry’s most important applications globally.  We are seeking a Medical Device Compliance Manager with a passion for product safety to help design, implement and manage a program to register and certify a group of InterSystems’ proprietary software products as medical device(s) around the world, and to maintain such certification as the product(s) evolve over time.  This position will have initial focus of the UK and European Union. Thereafter, it is expected that the company’s medical device certification will be expanded to other regions and will likely cover additional products

Responsibilities

  • Designing and presenting appropriate, risk-based medical device compliance programs for management approval
  • Day-to-day monitoring and reporting of medical device compliance risks
  • Coordinating and maintaining the certification for medical device products
  • Periodic training and education, both internally and externally
  • Coordinating responses to client questionnaires, requests and queries
  • Working with product design, development and testing teams to ensure medical device regulatory compliance
  • Maintain familiarity with global medical device regulations and national certification schemes
  • Manage and report on CAPA activities
  • Develop procedures for managing subcontrators and vendors to ensure medical device compliance
  • Design and recommend tools for managing compliance records and workflows related to medical device compliance
  • Assist product teams with clinical risk assessment and management.
  • International Travel will be required, particularly during the first year

Qualifications

  • 5 – 10 years of hands-on experience with regulatory compliance, preferably including medical device compliance for software products
  • Hands-on experience with ISO 9001 and ISO 13485 required. Experience with FDA QSR and CE directives such as Machinery Directive, Medical Device Directive, In Vitro Diagnostic Directive, MHRA regulations and Clinical Risk Management preferred
  • Hands-on auditing experience including conducting internal and external audits
  • Experience with managing Corrective and Preventive Action Programs
  • Experience with software lifecycle management a plus
  • Proven track record of interfacing with various groups in order to complete inter-deparmental projects
  • Ability to work across the organization with all levels of employees to ensure that the value of Quality Programs is understood and embraced

Education and Training

Bachelor’s degree or higher with hands-on experience creating quality system procedures which comply with ISO, FDA and/or European standards

About InterSystems

InterSystems is the information engine that powers some of the world’s most important applications. In healthcare, finance, government, and other sectors where lives and livelihoods are at stake, InterSystems has been a strategic technology provider since 1978. InterSystems is a privately held company headquartered in Cambridge, Massachusetts (USA), with offices worldwide, and its software products are used daily by millions of people in more than 100 countries.

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