Product Surveillance Specialist III

Posted 6 Days Ago
Be an Early Applicant
Racine, WI, USA
Hybrid
Junior
Beauty • Pharmaceutical
The Role
Handles post-market medical device complaints, including intake, documentation, troubleshooting, follow-up, investigations, product returns, record reviews, and closure. Assesses whether Medical Device Reports or vigilance reports are required, supports audits and process improvements, and maintains customer and stakeholder communication while ensuring compliance with applicable quality systems and regulations.
Summary Generated by Built In

About Us

Founded 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 Overview

The 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 Do

  • Key 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 Requirements

  • High School Diploma with 2 years of experience
  • Associate’s Degree with 1 year of experience
  • Customer Service Experience
  • Medical or Surgical Office Experience

Preferred Qualifications

    Technical & Functional Skills

    • Familiar 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.

    Benefits

    • Comprehensive Medical, Dental, and Vision plans
    • 20 days of Paid Time Off
    • 15 paid holidays
    • Paid Sick Leave
    • Paid Parental Leave
    • 401(k)
    • Employee bonuses
    • And more!
    • Your benefits and PTO start the date you're hired with no waiting period!

    Work Authorization  & Visa Sponsorship

    Applicants 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.

    Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
    This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

    Skills Required

    • High school diploma and 2 years of experience
    • Associate degree and 1 year of experience
    • Customer service experience
    • Medical or surgical office experience
    • Familiarity with ISO 13485 Quality System Standards, FDA Quality System Regulations, GMPs, and/or international medical device regulations
    • Basic medical and/or scientific terminology
    • Organization and attention to detail
    • Ability to prioritize and manage multiple records and reports
    • Professional phone etiquette and ability to handle sensitive information
    • Strong written and verbal communication skills
    • Ability to communicate effectively throughout the organization
    • Experience with Microsoft Office Suite
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    The Company
    HQ: Raleigh, North Carolina
    3,064 Employees

    What We Do

    Merz Aesthetics is a medical aesthetics business with a long history of empowering health care professionals, patients and employees to live every day with confidence. We aim to help people around the world look, feel and live like the best versions of themselves — however they define it. Clinically proven, its product portfolio includes injectables, devices and skin care treatments designed to meet each patient’s needs with high standards of safety and efficacy. Being family owned for more than 115 years, Merz Aesthetics is known for building unique connections with customers who feel like family. Merz Aesthetics’ global headquarters is in Raleigh, N.C., USA, with a commercial presence in 90 countries worldwide. It is also a part of Merz Group, which was founded in 1908 and is based in Frankfurt, Germany. Learn more at merzaesthetics.com.

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