Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.
JOB DESCRIPTION:
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.
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
The base pay for this position is
$78,000.00 – $156,000.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
HF Heart Failure
LOCATION:
United States > Massachusetts > Burlington : 168 Middlesex Turnpike
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
No
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf