New-Braunfels, TX Careers | Experis Jobs

Medical Compliance Specialist

Medical Compliance Specialist Location: San Antonio, TX (78261) Contract Length: 5 months (with possibility for extension) *** Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status), able to pass a federal government background check and possess a valid U.S. passport. Main Responsibilities: Prepares and maintains adverse event files and compiles adverse event investigation information. Investigates reports of potential adverse events and potentially reportable malfunctions and assesses potential reportable events to determine if regulatory filings are required. Maintains Regulatory databases and files. Plays a vital role in the preparation of various regulatory documents such as Medical Device and Vigilance reports. Gathers and compiles adverse event investigation information through employee and customer contact including phone solicitations to healthcare professionals. Coordinates adverse event investigations with co-workers and other departments to ensure compliance with regulatory timelines for completion. Manages and maintains adverse event files and MDR (Medical Device Report) tables. Creates, organizes and manages regulatory files and documentation including Food and Drug Administration (FDA) submissions, international submissions, annual reports, and ad hoc reports. Conforms to and enforces KCI policies and procedures as related to job function. Performs a role in corporate, departmental, and regulatory audits to record activities as may be deemed suitable and assigned by management. Minimum Qualifications: Bachelor of Medicine degree or Bachelor of Science degree in Nursing or other related medical degree (e.g. ...

Job Type:Contract

Location:San Antonio, TXDistance:32 miles

Date Posted:Jan 7, 20219 days ago

Industry:Health and Safety

Medical Compliance Specialist Location: San Antonio, TX (78261) Contract Length: 5 months (with possibility for extension) *** Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status), able to pass a federal government background check and possess a valid U.S. passport. Main Responsibilities: Prepares and maintains adverse event files and compiles adverse event investigation information. Investigates reports of potential adverse events and potentially reportable malfunctions and assesses potential reportable events to determine if regulatory filings are required. Maintains Regulatory databases and files. Plays a vital role in the preparation of various regulatory documents such as Medical Device and Vigilance reports. Gathers and compiles adverse event investigation information through employee and customer contact including phone solicitations to healthcare professionals. Coordinates adverse event investigations with co-workers and other departments to ensure compliance with regulatory timelines for completion. Manages and maintains adverse event files and MDR (Medical Device Report) tables. Creates, organizes and manages regulatory files and documentation including Food and Drug Administration (FDA) submissions, international submissions, annual reports, and ad hoc reports. Conforms to and enforces KCI policies and procedures as related to job function. Performs a role in corporate, departmental, and regulatory audits to record activities as may be deemed suitable and assigned by management. Minimum Qualifications: Bachelor of Medicine degree or Bachelor of Science degree in Nursing or other related medical degree (e.g. ...

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Medical Compliance Specialist

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