Clinical Specialist, Post Market Surveillance

Responsible for Medical Device Report (MDR) submission documentation and follow-up, including interaction with Complaint Analysts, Investigators, Customer Service, etc. Provide guidance on complaint expectations and record completeness.

Job Duties

• Assisting the department manager in ensuring all global medical device reports are filed within regulatory timeframes
• Represents Product Surveillance at cross-functional meetings as requested or in the absence of the department manager
• Assists in training new employees on complaint handling as well as maintaining training documents. Provides training on complaint reporting to other groups as required.
• Ensures complaint information is maintained
• Support inspections by regulatory agencies (e.g. FDA, TUV) as required
• Supporting and instructing other department members as needed on product complaint investigations and devices
• Collaborate independently with other team members and departments needing product complaint information
• Act as a clinical subject matter expert to the Product Surveillance team members
• Assist with and conduct investigations with customers or field staff with minimal direction, utilizing experience and knowledge of products and various types of product complaints
• Make sound decisions regarding medical device reporting to various global regulatory agencies
• Be able to ascertain when additional support may be needed from other teams on complaint investigations
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Performs other related duties and responsibilities as required.

Qualifications

• Four-year degree, preferably in the clinical, medical, scientific or healthcare fields; or 2-year degree with relevant experience.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Critical thinking and creative approach to problem solving with attention to detail.
• Proficient computer skills are required.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment as well as the ability to leverage and/or engage others to accomplish projects.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Knowledge of global regulations for medical device reporting and complaint handling is preferred.
• Minimum experience of 3 years