RAQA Post Market Risk Management Associat-Jobs in New Jersey
Description
Job Title RAQA Post Market Risk Management Associate
Division Stryker Corporate
Location (Country – State) United States – New Jersey
City or Sales Region Mahwah
Business Function Regulatory/Quality/Clinical Affairs
Shift N/A
Education and/or Special Training Bachelor’s degree (or equivalent educational experience) and licensed as a Registered Nurse or Physician’s Assistant.
Job Description The Post Market Risk Management Associate will be responsible for establishing a working relationship across all Stryker divisions to perform reviews of risk analysis for accuracy in assessment related to patient safety. In addition, the position will provide support for all divisions in review of product complaint information to ensure appropriate decision making for Adverse Event Reporting (MDR).
Job Duties:
- Applies clinical knowledge for review of Health Hazard Evaluations and complaint files
- Conducts follow-up contact with applicable parties (R&D, operations, marketing, surgeons, etc.) to gather pertinent information to complete evaluations for risk assessment/complaint files
- Works closely with medical review board to provide the necessary information to assure their input is appropriate to the hazards and harms
- Assure probability of occurrence and severity is consistently applied during failure investigation and risk analysis
- Approves Health Hazard Evaluations, health assessments, risk assessments and investigations justifications and utilizes an understanding of current approaches to the balance of risk and benefits
- Ensures compliance with ISO 14971-Medical Device Risk Management and other related FDA Regulations CFR 830 as they relate to recalls and adverse event reporting
- Reviews documentation to FDA for accuracy and for field communications when initiating Field Actions (recalls) to ensure all risks have been incorporated
- Applies clinical experience to complete complaint files associated with rationale for adverse event reporting
- Ensures a uniform reporting is applied across all Stryker divisions for adverse event reporting and risk evaluation
- Maintains database for tracking and provides metrics
Qualifications/Work Experience - 7-10 years total practical medical experience
- 3-5 years participating in Orthopedic surgery preferred
- Risk Management experience a plus
- Industry experience in Medical Device/Pharmacovigilance/Biotech
Percent Travel Required 10%
Requisition ID 9940BR
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