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Role: Post market Surveillance Analyst II

Location: Plymouth, MN - 55442

Duration: 12 Months on W2

Shift Timings: 8:00 AM to 4:30 PM

Job Description:

• Initiates and manages the complaint file
• maintains accurate entry of complaints in the database
• communicates to field representatives regarding information needed specific to product complaints (e.G. physicians, hospital personnel, sales representatives, international offices)
• independently assesses the complaint to determine if a medical device report needs to be filed with various global regulatory agencies (e.g. FDA, ECA) and submits reports within required time frame
• diligent of any unusual trends in product complaints and communicates them with mgmt.,
• complies with US 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.
• Performs other related duties and responsibilities as assigned

Note:

• Under the direction of the department manager, the Post market Surveillance Analyst will perform all file management activities pertaining to product complaints for the Structural Heart division (link removed)
• This includes, but is not limited to: receiving and assessing reports of worldwide complaints/events on a variety of products
• entering information into the complaint database
• independently determining and filing appropriate medical devices reports with various regulatory agencies
• coordinating with internal resources to meet regulated timelines
• participating on cross-functional teams; and providing information on product complaints
• including data extracted from the complaint database, to various teams (e.g. Regulatory, Quality Engineering).