The Clinician Complaint Handling Specialist will play a crucial role in assessing and managing complaints related to the combination products team. This position requires a strong understanding of medical devices, and regulatory compliance. They will be partnering with a Complaints Specialist and will be overseeing around 10-15 complaints per week. This role is fully remote.
Key Responsibilities:
-Conduct thorough investigations of product complaints, collaborating with cross-functional teams.
-Utilize RN expertise to assess the validity and severity of complaints.
-Perform reportability assessments to determine if an event is reportable to regulatory authorities.
-Utilize Veeva for complaint handling and documentation.
-Maintain accurate records of complaint investigations and resolutions.
-Collaborate with Quality Assurance and Regulatory Affairs teams to ensure compliance with relevant regulations.
- Provide feedback for product quality improvements.
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to
HR@insightglobal.com.
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-Previous experience with medical devices or combination products.
-Proficiency in reportability assessments and understanding of regulatory requirements.
-Familiarity with Trackwise or Veeva complaint management systems.
-Excellent reading and reviewing skills, especially related to adverse events.
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.