Senior Quality Compliance Specialist
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Senior Quality Compliance Specialist
Title:Senior Quality Compliance Specialist
Senior Quality Compliance Specialist:
- Assess complaints (root cause analysis) and determine if an investigation is required and document rationale if investigation is not required.
- Execute timely analysis and reporting of adverse events and complete communication within the global regulatory time frames. Also monitor, trends and track the timeliness of investigations and closure.
- Communicate directly with national and international competent authorities on complaint/AE related questions (examples: FDA, Health Canada, BfArM, TGA, MHRA, MHLW, etc.)
- Communicate directly with notified body, internal/external customers, distributors, physicians, suppliers and manufacturers to ensure timely completion of activities related to complaint and failure investigations.
- Analyze information obtained during complaint investigations and prioritize complaint investigations to ensure that they are processed in a timely manner.
- Conduct meetings, track action items and prepare documents related to complaints, vigilance, health hazard evaluations, CAPA, post-market surveillance and recalls.
- Generate and review data and documents for compliance with U.S. and international regulations and requirements (ISO 13485, 14971, etc.).
- Ensure that Company’s records, procedures, specifications, policies etc. comply with Federal, international and corporate standards, or other external regulations and requirements
- Create documentation and train departmental and corporate personnel on the complaint handling, adverse event/vigilance reporting requirements and monitor compliance.
- Responsible for staying current on international regulations and incorporating any revision or changes needed into SOP’s, work instructions, etc.
- Bachelor degree in biology, health sciences, engineering, nursing or other related discipline.
- Must have a broad understanding of regulatory and compliance issues that drive the medical device industry, including those outside of the area of his/her expertise.
- Should have knowledge of quality system regulations, MDR reporting system and adverse event processes.
- Must possess good verbal and written communication skills with an investigative mindset and critical analysis skills.
- Working knowledge of Microsoft Office software (Word, Excel, PowerPoint, Outlook).
- Minimum 3 years’ direct experience in adverse event/MDR compliance role.
- Must have previous experience in complaint handling and adverse event reporting.
- Experience working with a database is preferred
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