Job Description
RESPONSIBILITIES:
- Responsible for the review, analysis, and summation of medical records and images (e.g., CT) provided in conjunction customer complaints, for inclusion into investigational reports.
- Participation in the decision making, development, and/or review process related to Medical Device Reporting (MDR) and/or Vigilance or other international reporting.
- Collaborates with Sales personnel, Customer Service, Engineering, Manufacturing, Quality Assurance, Clinical Affairs, EU Representative, distributors and physician users in these investigations.
- Supports regulatory body interface related to inquiries associated with adverse event reporting.
- Provides clinical/medical input regarding classification of hazards and associated risk management activities.
- Provides clinical and technical assistance and training
- Interfaces with hospital personnel and physicians involving adverse events.
- Interfaces with internal and external customers with regard to the clinical impact adverse events. Performs customer site visits, as necessary.
- Drafts and/or reviews customer results letters related to customer experiences.
- Provides clinical/medical input for new and revised labeling.
- Provides clinical/medical input and support to development team in generating risk management activities.
- Supports internal corporate, notified body, 3rd party, and regulatory agency audits.
- Prepares reports for periodic management reviews or other purposes.
- Perform other duties as assigned by supervisor
QUALIFICATIONS:
Education:
- Registered Nurse (RN) or other applicable clinical/medical license or degree.
Experience:
years of related work experience, including:
- Minimum of 3 years of medical device experience (Class II/III) or a combination of clinical and medical device experience
- Prior experience with MDR/Vigilance and other internal regulatory reporting
- Comprehensive knowledge of quality systems and relationship to business.
- Ability to facilitate and provide leadership concerning investigational activities.
- Must demonstrate technical writing ability.
- Good interpersonal skills including ability to interact with high degree of diplomacy.
- Ability to work in a fast-paced, technically challenging environment where drive is critical to success.
- Must be self-motivated and self-disciplined and able to prioritize and handle multiple tasks and responsibilities.
- Effective problem solving techniques and excellent applied thinking skills.
- Strong communication and organization skills required.
- Expertise in Microsoft Office applications and charting programs.