Product Surveillance Specialist III

Summary

Product Surveillance Specialist III (Finance)About UsFounded in 1908, Merz is a successful, family-owned specialty healthcare company with a rich history. As a leading global aesthetics business, our award-winning portfolio of injectables, devices, and skincare products empowers healthcare professionals to enhance confidence through aesthetic medicine. Our purpose is to fuel confidence by helping people look better, feel better, and live better. We believe you do not have to choose between living life and making a living. Live your best life with Merz Aesthetics.A Brief OverviewThe Product Surveillance Specialist III performs day-to-day tasks and provides technical data assessment of post-market events. This position plays an integral role in maintaining compliance with global regulations. The Product Surveillance Specialist III works with close to moderate supervision and requires a high degree of interaction with customers, health care professionals, and Global Merz employees.What You Will DoKey Responsibilities * Field inquiries received by phone, electronic or verbal correspondence and determine if it qualifies as a complaint; document reported issues according to applicable SOP(s).* Provide technical support and remote troubleshooting guidance as needed.* Review associated records, and contact users and customers to collect information on the treatment, product performance, functionality, etc. * Conduct periodic follow-up to close complaints in a timely manner.* Manage customer relationship and expectations during the course of the complaint investigation.* 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. * Develop solutions to a variety of basic problems, applying established guidelines.* Support training program by completing assigned training in a timely manner.Process Improvement Initiatives * Support operational changes to improve efficiencies in all aspects of complaint handling.Compliance Initiatives * Support internal and external quality system audits, following guidance from manager.* Evaluate complaints and determine if the submission of a Medical Device Report (MDR) or other Vigilance Report is required, using established guidelines.Other Duties Employees will be required to follow any other job-related instructions and to perform any other job-related duties required by their supervisor.Minimum RequirementsHigh School Diploma with 2 years of experienceAssociate's Degree with 1 year of experienceCustomer Service ExperienceMedical or Surgical Office ExperiencePreferred QualificationsTechnical & Functional SkillsFamiliar with ISO 13485 Quality System Standards, FDA Quality System Regulations, GMPs, and/or other international medical device regulations.Basic medical and/or scientific terminology.Organized with attention to detail.Able to prioritize and manage multiple records/reports simultaneously.Professional phone etiquette with the ability to appropriately handle sensitive information.Good communication skills including written and verbal.Ability to work with company staff and communicate effectively throughout the organization.Experience with Microsoft Office Suite.BenefitsComprehensive Medical, Dental, and Vision plans20 days of Paid Time Off15 paid holidaysPaid Sick LeavePaid Parental Leave401(k)Employee bonusesAnd more!Your benefits and PTO start the date you're hired with no waiting period!Work Authorization & Visa SponsorshipApplicants must be authorized to work in the United States without the need for employment-based visa sponsorship now or in the future . Merz will not sponsor applicants for U.S. work visa status for this opportunity. No sponsorship is available for any employment-based visas, including but not limited to H-1B, L-1, TN, O-1, E-3, H-1B1, F-1, J-1, OPT, CPT , or any other employment-based visa category.#J-18808-Ljbffr

Job Description

Product Surveillance Specialist III (Finance)About UsFounded in 1908, Merz is a successful, family-owned specialty healthcare company with a rich history. As a leading global aesthetics business, our award-winning portfolio of injectables, devices, and skincare products empowers healthcare professionals to enhance confidence through aesthetic medicine. Our purpose is to fuel confidence by helping people look better, feel better, and live better. We believe you do not have to choose between living life and making a living. Live your best life with Merz Aesthetics.A Brief OverviewThe Product Surveillance Specialist III performs day-to-day tasks and provides technical data assessment of post-market events. This position plays an integral role in maintaining compliance with global regulations. The Product Surveillance Specialist III works with close to moderate supervision and requires a high degree of interaction with customers, health care professionals, and Global Merz employees.What You Will DoKey Responsibilities * Field inquiries received by phone, electronic or verbal correspondence and determine if it qualifies as a complaint; document reported issues according to applicable SOP(s).* Provide technical support and remote troubleshooting guidance as needed.* Review associated records, and contact users and customers to collect information on the treatment, product performance, functionality, etc. * Conduct periodic follow-up to close complaints in a timely manner.* Manage customer relationship and expectations during the course of the complaint investigation.* 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. * Develop solutions to a variety of basic problems, applying established guidelines.* Support training program by completing assigned training in a timely manner.Process Improvement Initiatives * Support operational changes to improve efficiencies in all aspects of complaint handling.Compliance Initiatives * Support internal and external quality system audits, following guidance from manager.* Evaluate complaints and determine if the submission of a Medical Device Report (MDR) or other Vigilance Report is required, using established guidelines.Other Duties Employees will be required to follow any other job-related instructions and to perform any other job-related duties required by their supervisor.Minimum RequirementsHigh School Diploma with 2 years of experienceAssociate's Degree with 1 year of experienceCustomer Service ExperienceMedical or Surgical Office ExperiencePreferred QualificationsTechnical & Functional SkillsFamiliar with ISO 13485 Quality System Standards, FDA Quality System Regulations, GMPs, and/or other international medical device regulations.Basic medical and/or scientific terminology.Organized with attention to detail.Able to prioritize and manage multiple records/reports simultaneously.Professional phone etiquette with the ability to appropriately handle sensitive information.Good communication skills including written and verbal.Ability to work with company staff and communicate effectively throughout the organization.Experience with Microsoft Office Suite.BenefitsComprehensive Medical, Dental, and Vision plans20 days of Paid Time Off15 paid holidaysPaid Sick LeavePaid Parental Leave401(k)Employee bonusesAnd more!Your benefits and PTO start the date you're hired with no waiting period!Work Authorization & Visa SponsorshipApplicants must be authorized to work in the United States without the need for employment-based visa sponsorship now or in the future . Merz will not sponsor applicants for U.S. work visa status for this opportunity. No sponsorship is available for any employment-based visas, including but not limited to H-1B, L-1, TN, O-1, E-3, H-1B1, F-1, J-1, OPT, CPT , or any other employment-based visa category.#J-18808-Ljbffr