Sr. Regulatory Compliance Specialist – Osseo

Responsible for assessing, processing and documenting complaints for the Interventional Cardiology Business Unit. Evaluate complaints for MDR reportability per 21 CFR 803 and organizational procedure. Prepare and submit MDR for submission to the FDA in the required time. Conduct clinical follow up with customers to obtain all relevant information on adverse events. Interprets federal and/or international regulations as they apply to products, processes, practices and procedures. Generate and/or review customer letters to assure they are factual and accurate and portray BSC's concern related to the complaint. Follows implemented policies and procedures to ensure compliance with the appropriate statutes and regulations. Investigates and resolves compliance issues associated with the Complaint Management Center. Assist with the development and maintenance of departmental procedures and policies. May audit and evaluate current policies, procedures, and documentation for compliance with government laws and regulations. Other duties as assigned.

Required Qualifications:
Bachelor’s degree in scientific discipline or technical field or equivalent work experience is required.
Previous regulatory experience including complaint handling is preferred.
Computer proficiency and database knowledge is required.
Experience in a drug/device manufacturer/distributor, with strong concentration in QSR compliance and quality assurance is preferred.
Clinical experience in either industry or hospital environment is preferred.
Strong analytical, organizational and communication skills required.

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