Summary of Position with General Responsibilities:
Provide clinical/medical insight into the complaint handling process at Bard Peripheral Vascular.
Essential Job Functions:
Participation in the decision making, development, and/or review process related to post-market adverse event reporting in the U.S. (Medical Device Reporting -MDR), Europe (Medical Device Vigilance -MDV), and other adverse event reporting requirements for International regulatory bodies around the world.

Participant in the decision making, development, and/or review process related to product complaints.

Interfaces with worldwide regulatory bodies related to inquiries associated with customer complaints and adverse events.

Responsible for reviewing patient medical records involving customer complaints.

Assessment of severity level of customer complaints.

Participation in the development of preliminary Health Hazard Evaluations for Division Remedial Action Plans, and reviews and approvals of product analysis, and failure investigations, as required.

Collaborates with Corporate Medical Director on Health Hazard Evaluations for Division, Remedial Action Plans, and reviews of complaints with regard to patient risk and safety.

Provides clinical and technical assistance and training to the Corporate Medical Services and Support Group on BPV’s products.

Provides training to internal customers (example: sales/marketing departments) regarding Bard's complaint handling process and requirements.

Interfaces with hospital Risk Management and physicians involving complex adverse events.

Interfaces with internal and external customers with regard to the clinical impact of finished product quality issues and customer dissatisfaction. Perform customer site visits, as necessary.

Drafts and/or reviews customer results letters related to complaints.

Provides Clinical input for new IFU and IFU revisions and provides input relative to new standards requirements.

Provides Clinical/Medical input and support to new product development teams and quality engineering staff in generating Risk Management Files (Risk Assessment, DFMEA, PFMEA).

Supports internal, corporate, notified body, 3rd party, and regulatory agency audits.

Perform other duties at the direction of the department head.

Basic Qualifications:
Strong organizational and analytical skills.
Excellent communication skills, both written and oral.
Ability to interact effectively on a team and with internal and external customers.

Additional Desirable Qualifications Skills and Knowledge:
Radiology or Cardiology cath lab or Vascular Surgery experience, Medical Facility Risk Management/Quality Assurance experience.

Prior experience with MedWatch and Foreign Report submissions, or a strong knowledge of and experience with FDA Quality System Regulations and Guidelines, Medical Device Directives, associated harmonized standards, ISO 13485, and related quality standards.

Education and/or Experience:
RN or other appropriate clinical license or degree with 8+ years of related experience.

Experience working in a cath lab, cardiology, radiology or vascular environment.

Computer proficiency with the standard software programs, i.e. Microsoft Word, Excel, PowerPoint