Clinical Specialist, Post Market Surveillance

Abbott•Burlington, MA

5d•$78,000 - $156,000•Onsite

About The Position

Under the direction of the department manager, the Clinical Specialist, Post Market Surveillance is a clinical subject matter expert for the Product Surveillance Department and able to demonstrate sound independent decision making global medical device reporting and other functions relating to the investigation of product complaints. 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.

Requirements

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.
Minimum experience of 3 years

Nice To Haves

Knowledge of global regulations for medical device reporting and complaint handling is preferred.

Responsibilities

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.