Position Overview

Responsible for the coordination and execution of Post Market Surveillance activities aligned with global regulations with a focus on the EU Medical Device Regulation (MDR). Ensure assigned regulatory tasks are completed accurately and in a timely manner while maintaining compliance to internal standards/procedures and applicable external industry regulations. Perform high-level post-market surveillance activities and projects associated with global regulatory compliance, and quality improvements. Job duties:
  • Create Periodic Safety Update Reports, Post Market Surveillance Plans/ Reports in line with defined process and schedule for all product lines.
  • Coordinate the gathering of the necessary data to create the plans and reports for all product lines.
  • Evaluate the data received to ensure it meets defined parameters and organizes the data into the plans and reports.
  • Develop relationships with key internal and external customers to identify, facilitate, strategize, and prioritize the necessary activities to meet the business objectives.
  • Support and participate in Post Market Surveillance Committee meetings that review product surveillance data.
  • Draft, organize, and ensure timely response to requests for additional information from National Competent Authorities on a global scale, requiring partnership across multiple business functions and senior leadership.
  • Collaborate with company’s Authorized Representatives regarding Vigilance responsibilities and MicroVention Europe Customer Service procedures.
  • Review product investigation root cause/conclusions and collaborate with the Lab or engineering staff, as needed, for inclusion in regulatory reports and customer responses.
  • Assist in the development and execution of associated department procedures and work instructions.
  • Assist in the development, planning, and delivery of training to staff and other teams to ensure efficient processes and compliance to regulatory requirements.
  • Initiate or participate in various continuous improvement projects that lead to the development of robust processes.
  • Assist in the preparation of company audits and compose written responses to any audit findings, as assigned. Assist with the management of CAPA responsibilities related to post-market surveillance processes.
  • Perform additional duties and responsibilities as assigned.

    • Bachelor’s degree or equivalent combination of education and relevant experience.
    • Minimum of four (4) years of regulatory or post-market surveillance experience with Class II/III vascular intervention, surgical/implantable, or neurological interventional medical devices.
    • In-depth knowledge of EU MDR 2017/ 745, ISO 13485:2016, FDA 21 CFR part 7/806/820, Vigilance (MEDDEV), and Canadian adverse event reporting regulations for Class II and Class III medical devices.
    • Strong analytical and critical thinking skills with the ability to make sound judgments based on objective data and acquired knowledge.
    • Excellent writing/composition skills with the ability to construct clear and comprehensive clinical/technical narratives.
    • Excellent verbal communication skills, with demonstrated success in establishing andmaintaining effective interpersonal relationships, with the ability to influence and leadothers.
    • Excellent time management skills with the proven ability to prioritize daily conflictingdemands to meet strict regulatory compliance and organizational deadlines.
    • Excellent cross-functional team collaborative skills.
    • Proficient with MS Word, Excel, Outlook, and Teams.
    Desired Qualifications
    • Experience with EU MDR regulations, project management, and process improvement initiatives.
    • Knowledge of pre-market Regulatory Affairs and Clinical Research practices and Requirements.