Manager, Product Complaint Handling

Manger, Product Complaint Handling - St. Jude Medical (Plano, TX)
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This position is the process owner for product complaint handling for St. Jude Medical Neuromodulation Division. Responsible for process and systems, developing, maintaining and tracking corporate complaint procedures and monitoring performance of the complaint handling process.

Major, On-Going Responsibilities:
• Establish clear policies and procedures for complaint handling for all locations within the Neuromodulation Division that are compliant with current regulations.
• Responsible for timely complaint closures and linkages of investigations to individual complaint records
• Ensure complaint and MDR reporting requirements are understood and met
• Support the reporting and follow-up of product recalls, if any
• Remain current on related regulations and guidelines published by FDA and international regulatory authorities
• Research various actions taken by FDA and other regulatory bodies to gain insight into current enforcement practices and the Agency’s rationale for such actions
• Provide interpretations and direction to appropriate personnel regarding the regulatory requirements relevant to the Product Complaint and Field Support organizations
• Initiate changes to practices and procedures to ensure compliance with internal and external requirements
• Design and provide training on topics related to the compliance of the product complaint SOP’s for all applicable employees
• Bring regulatory compliance questions/issues to the attention of senior management
• Participate in internal compliance inspections/audits, as well as support other units during inspections as requested

Education & Training:
• Bachelors Degree in Engineering or related discipline
• 5+ years relevant work experience, managing complaints, MDR and recalls
• 3+ years experience applying regulations including FDA QSRs, ISO13485
• 3+ years experience in medical device or pharmaceutical industry
• Ability to understand technology, products and procedures of the supported modalities. A thorough understanding of related U.S. Regulatory laws to ensure compliance.
• Demonstrated strong written and oral communication skills
• Ability to build strong relationships, team oriented
• Ability to influence positive change effectively
• Proficient with Microsoft Office Suite (e.g., database software programs)
Other Skills/Characteristics:
• Attention to Detail – establishes and reinforces consistency, carelessness is not tolerated
• Communicates Effectively – adjusts the message to the audience to get the point across
• Decisive & Good Judgment – decisions are based on data and sound reasoning
• Influencing – champion initiatives that generate organization-wide understanding and support
• Problem solving – establish resources, processes to gather information/data for problem solving or analysis