Global Regulatory Compliance & Post-Market Surveillance Specialist I
Why Join ACIST?
We care as much about our employees as we do our patients. Our culture fosters a work environment where employees can thrive, be passionate and have fun along the way. Each member of the ACIST team has the power to make a difference......every day!
Performs product complaint and post-market surveillance activities on a global basis for ACIST and BINJ products. Ensures compliance with global standards and regulations, including but not limited to: FDA’s Quality System Regulations (21 CFR 820), ISO 13485, Medical Device Directive (93/42/EEC), the Canadian Medical Device Regulations, Brazil’s Resolution RDC No. 59, China SFDA Regulations for the Supervision and Administration of Medical Devices, Japan’s Ministerial Ordinance 169, and Korea’s Medical Device Regulation.
Primary Duties and Responsibilities:
Support and maintenance of post-market activities associated with customer complaints:
• Monitor and manage the global Complaint Handling process to ensure timely and accurate processing of complaints, and fulfillment of customer and regulatory expectations
• Facilitate the progress of complaints throughout the complaint lifecycle to ensure proper documentation and timely closure of each complaint
• Collaborate with Customer Support, Engineering, and Service teams to support complaint activities
• Review and approve Engineering Investigations and Service Reports for accuracy, completeness and content, providing feedback for improvements
• Prepare customer communications for complaints
• Generate global complaint trending reports for analysis
• Lead monthly cross-functional, cross-site complaint meetings to analyze complaint data and determine actions taken to drive improvements in regulatory compliance, product performance and customer satisfaction
• Contribute to Complaint Handling process requirements, including global standard operating procedures (SOPs) and Work Instructions (WIs), that ensure compliance with evolving global standards and regulations
• Contribute to continuous improvements to the global Complaint Handling process
• Generate global complaint data reports for ACIST Key Quality Metrics Reports, Annual Management Review Reports, and as requested
• Proactively monitor customer feedback from global sources to provide early warning of actual or potential quality problems directly or indirectly involving ACIST products
• Meet team and individual output goals
• Develop and maintain product knowledge of existing and new products
Support and maintenance of global vigilance and post-market activities:
• Analyze product complaints holistically and make critical judgments on potential reportability of adverse events to global regulators
• Support global Vigilance reporting requirements, such as MedWatch reports for FDA reporting and Vigilance Reports to the appropriate European Competent Authorities, Australia’s Therapeutic Goods Administration, etc.
• Assist in preparing correspondence to global regulatory agencies requests for additional information
• Prepare Annual Global Post-Market Surveillance Reports
• Provide Global Complaint Data for input to Annual Clinical Evaluation reports, Annual Risk Reports, Health Risk Assessments, Failure Modes Effects Analysis (FMEA), Fault Tree Analysis
• Assist in Regulatory Inspections (FDA, PMDA, ANVISA, KFDA, etc.) and 3rd Party Audits (ISO, Customers, Partners, etc.)
• Participate in CAPA investigation and action plan development that may result from Regulatory Inspections, 3rd Party Audits and Internal Audits
• Assist with global product recall activities
• Other duties as assigned
Qualifications (Knowledge, Skills & Abilities):
• Bachelor’s degree in Science or Engineering, or Associates degree plus equivalent experience
• Ability to read, analyze and interpret regulatory communications and complaint data
• Must have strong verbal and written communication skills, initiative, flexibility, creative thinking and the ability to understand the underlying technical principles of ACIST products
• Must also have the ability to work with individuals in a congenial and cooperative manner
• Experience working on cross-functional teams
• Ability to develop clear, concise, and timely oral and written reports.
• Must have strong organizational skills and effective work habits.
• Proficient personal computer skills including Microsoft Office, database activity, spreadsheet, graphics, etc.
• Previous Complaint Handling experience in the medical device industry
• Experience with minimally invasive medical devices
• Experience with TrackWise or other validated software used in complaint management
• Mental demands – work is detail oriented, often with multiple priorities. The environment is deadline sensitive and may be exposed to high-pressure situations.
• Travel requirements are minimal. Travel would be about 2 – 3 days duration each trip with total travel expected to be less than 5%.