Post Market Surveillance Specialist II

Job Description

Position Summary:

Performs product complaint and post-market surveillance activities on a global basis for ACIST 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 & 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
• Contribute to Complaint Handling process requirements, including Global SOPs and Work Instructions, that ensure compliance with evolving Global Standards and Regulations
• Contribute to continuous improvements to the Global Complaint Handling process
• 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
• Generate Global complaint data reports for ACIST Key Quality Metrics Reports and Annual Management Review Reports
• Assists with Medical Advisory Board meetings, preparing and presenting data and reports 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.
• Assist in preparing correspondence to global regulatory agencies such as MedWatch reports to the FDA, Vigilance reports to European Competent Authorities, etc.
• 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

Other

• Support the validation of Global Software Tools used in the Complaints Process including TrackWise, SFDC, e-MDR, etc.
• Assist in Regulatory Inspections (FDA, MDSAP, etc.)
• Participate in CAPA investigation and action plan development that may result from Regulatory Inspections, Third-Party Audits and Internal Audits
• Assist with Global product recall activities
• Other duties as assigned

Required Skills

Minimum

• Where permitted by applicable law, must have received or be willing to receive the COVID-19 vaccine by date of hire to be considered for U.S.-based job, if not currently employed by ACIST Medical Systems
• BA or BS degree or a combination of education and experience providing equivalent knowledge
• 2+ years Complaint Handling experience in the medical device or a regulated industry
• Working knowledge and experience with ISO 13485, 21CFR 820
• Familiarity with 21 CFR 803 Medical Device Reporting and ISO 14971 Risk Management.
• 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 organized and effective work habits.
• Proficient personal computer skills including Microsoft Office, database activity, word processing, spreadsheet, graphics, etc.

Preferred:

• Previous Complaint Handling experience
• Experience with cardiovascular medical devices
• Experience with TrackWise or other validated software used in complaint management

Other:

• 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%.