Position Overview

The Post Market Clinical Manager, Product Safety will provide medical expertise in the evaluation of post-market safety data from a variety of sources as part of the overall post market surveillance process.The successful candidate leads the detection and analysis of potential field safety risk and ensures appropriate communication and escalation to management. ThePost Market Clinical Managerisresponsible for continuous safety signal detection and the medical evaluation of patient safety risk according to respective regulation and company procedures. Typical job duties might include:
  • Medical Advisor to Field Assurance for global regulatory reporting determinations.
  • Provide medical guidance to Field Assurance analysts and engineers regarding interpretation of clinical complaints and correlation with returned product investigations.
  • Assess adverse event reports related to post market clinical trials for complaint and reportability determination.
  • Effectively communicates with the customers, as needed, regarding product safety issues.
  • Participate in continuous improvement activities and training opportunities within Field Assurance and the Returned Goods (RG) Lab.
  • Serve as a medical liaison for responses to regulatory authorities and external customers, providing information on disease states and clinical considerations related to complaints and product performance.
  • Responsible for Health Hazard Evaluations (HHE) and Product Risk Evaluations (PRE), as required by company procedures.
  • Participate in the Risk Management processes to enhance the incorporation of clinical field experience product risk analysis.
  • Participate in various projects that lead to the development of robust post-market surveillance of MicroVention products.
  • Responsible for periodic (as required by company procedures) and at-demand clinical literature review and reports respective to post-market MicroVention and competitor product performance.
  • Collaborates with Post-Market Quality and Regulatory Affairs for writing Post-Market Surveillance Reports, as required by regulations.
  • Engage in post-market surveillance activities and data analyses supporting product safety initiatives.
  • Partner with Quality, Risk Management, Engineering, Product Development, Clinical., regulatory, and Post-Market Surveillance teams to ensure effective compliance to Quality standards with regards to product safety.
  • Construct, review, and approve narratives for global regulatory inquiry responses and product safety positions, as well as for regulatory audits/inspections responses, as needed.

    • An advanced degree in health sciences from accredited institution (MD, PhD) or internationally equivalent degree is required.
    • Five plus (5+) years of clinical/medical device safety experience.
    • Excellent written and verbal communication skills
    • Proficient with MS Word, Excel, Teams, and Outlook
    Desired Qualifications
    • Experience with Class III medical devices.
    • Excellent medical writing skills.
    • Knowledgeable in global regulatory reporting requirements.
    • Demonstrated success in effective interpersonal and oral/written communication skills, with the ability to influence and lead others who may or may not be part of direct team.
    • Excellent decision making/analysis skills; ability to manage multiple projects simultaneously.
    • Successful cross-functional team collaborative skills.
    • Results-oriented self-starter with the ability to work independently to achieve on-time deliverables.
    • High reliability and quality focus.
    • High engagement, motivation and flexibility.
    • Good understanding of customer needs.
    • Strong problem-solving skills.
    • Excellent organizational and prioritization skills.
    • Knowledge of GMP, HIPAA, 21 CFR Parts 803, 806, and 820, ISO13485, ISO14971, EU Medical Device Regulation 2017/745, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169;as well as other relevant domestic and international product safety standards.