Analyst II Postmarket Surveillance

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We are seeking an Analyst II, Postmarket Surveillance for a very important client.

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 timeframe, 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

o Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.
o Apply clinical knowledge, as related to product application, to evaluate identified complaints.
o Investigate complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis.
o Establish regulatory reportability decisions using event investigation and regulatory decision models.
o Participate in development and modification of these decision models with changes in product advances/therapies to uphold consistent compliance with government-mandated regulations.
o Write Medical Device Reports (MDRs), MedWatch, Vigilance, and other regulatory reports, ensuring timely transmission to the appropriate regulatory authorities.
o Apply codes to events to facilitate product performance records.
o Review coding and investigations with engineering, laboratory, and other internal staff.
o Compose written communications detailing the clinical observation, investigation and/or product analysis, and corrective actions, as applicable, to physician and other end use customers.
o Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.
o Apply clinical knowledge, as related to product application, to evaluate identified complaints.
o Investigate complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis.
o Establish regulatory reportability decisions using event investigation and regulatory decision models.
o Participate in development and modification of these decision models with changes in product advances/therapies to uphold consistent compliance with government-mandated regulations.
o Write Medical Device Reports (MDRs), MedWatch, Vigilance, and other regulatory reports, ensuring timely transmission to the appropriate regulatory authorities.
o Apply codes to events to facilitate product performance records.
o Review coding and investigations with engineering, laboratory, and other internal staff.
o Compose written communications detailing the clinical observation, investigation and/or product analysis, and corrective actions, as applicable, to physician and other end use customers.
o Communications include determination/eligibility for warranty credit or unreimbursed medical payments.
Requirement:
The ideal candidate will possess the following qualifications:

The most helpful qualities for success in this position are good organizational skills, ability to prioritize, and attention to detail. We have people in this role with a wide variety of backgrounds, but of course prior complaint handling experience or experience in the medical field is helpful
How to Apply:
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