Assoc/Assoc I - Product Surveillance

Essential Duties and Responsibilities

• Effectively manage and process complaints and/or MDRs, which includes performing daily tasks associate with processing complaint files and MDRs across multiple product lines, which may include:
  • Opening complaint records.
  • Collecting necessary complaint information.
  • Performing follow-up with the customer (written and verbal).
  • Determining reportability of complaints.
  • Creating associate Regulatory reports (e.g., MDRs) per regulations.
  • Evaluating complaints for need to investigate and coordinating sample retrieval.
  • Responding to customer complaints (written and verbal).
  • Timely closure of complaints, as per procedure.
• Effectively manage workflow, identifying and escalating issues.
• Triaging internal and external communication for complaints.
• Participate in continuous improvement efforts and projects, as assigned.
• May mentor and/or provide training guidance to new team members.
• May oversee complaint handling and reporting activities performed by less senior employee

Qualifications

• Fluent in English: solid written and verbal communication skills.
• Ability to prioritize and multitask.
• Proficient with computers.
• Ability to work with cross-functional teams to interact effectively with peers, management and customers.
• Readily accepting of assignments to new/different products.
• Strong critical thinking and problem-solving skills.
• Ability to work independently.
• Detail oriented.
• Customer focused.

Education and/or Experience

• Minimum of an Associate s Degree required in nursing, pharmacy, medical technology, engineering or scientific background (MLT, LPN, RN) or equivalent experience (defined as a minimum of 3 years of medical products industry experience). Bachelor degree and/or clinical certification (MT, RN) preferred
• 2-3 years work experience in a cGMP related industry or in a clinical setting
• Project Management experience and/or certification preferred

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.