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Product Surveillance Associate II

The Product Surveillance Associate II provides clinical and safety data assessment of post-marketing events. This position plays an integral role in maintaining compliance with global regulations.
This position works with minimal supervision and requires a high degree of interaction with customers, health care professionals, global government agencies and Global Merz employees at all levels within the organization.
Major duties
Product Surveillance Activities
Field inquiries received by phone, electronic or verbal correspondence and document reported complaints according to applicable SOP(s). Provide technical support and remote troubleshooting guidance as needed.
Review associated records; provide technical guidance, and contact users and customers to collect information on the treatment, product performance, functionality, etc.
Complete investigations, which may include execution or coordination of product returns and subsequent evaluations, review of manufacturing records and ensuring proper approvals are obtained as part of closure.
Conduct statistical analysis of complaint trends.
Train users on the complaint process and tools used to assess and investigate complaints.
Support NCR and CAPA activities
Support investigations associated with product deviations, product non-conformances, CAPAs, scrap and rework, and analyzing the data for the reasons of Quality Improvement and reporting.
Process Improvement Initiatives
Recommend and implement operational changes to improve efficiencies in all aspects of complaint handling.
Adherence to Regulations
Evaluate complaints and determine if the submission of a Medical Device Report (MDR) or other Vigilance Report is required. Submit MDRs and Vigilance Reports according to regulatory timelines.
Maintain awareness of changes to global regulatory requirements related to complaint handling and adverse event reporting.
Education
Bachelor's Degree -Required
Bachelor of Science or Bachelor of Engineering -Preferred
Professional experience
Medical Device -Preferred
Medical or surgical office experience -Preferred
2-4 years experience in Medical Device, Pharmaceutical and/or equivalent regulated industry Required
Knowledge, skills and abilities (incl. languages)
Prioritizing and managing complaint reports -Preferred
Microsoft Outlook, Word, Excel, Powerpoint -Preferred
Medical and/or scientific terminology -Required
Professional phone etiquette plus careful handling of sensitive information -Required
English fluency (read, write) -Required
Knowledge of methods
Database or CRM system
Personal skills
Organized, attention to detail -Required
Highly effective communication skills. Ability to work with company staff and communicate effectively throughout the organization. -Required



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