Medical Device Reporting Specialist || Atlanta GA || Onsite || W2 Role || 5 days onsite

PRINCIPAL RESPONSIBILITIES:

· Manual intake of complaints from functional mailbox account to SFDC complaint creation.

· Monitoring of list views for intake of automated complaints created.

· Manual movement of complaints from open to evaluation state incase stuck in open state for more than 24 hours from date created (or as otherwise instructed by Leadership / internal SOPs)

· Perform good faith efforts (GFE), as applicable.

· Complaint determination

· Duplicate check

· Complaint split, as applicable.

· Medical device reporting determination; escalation to Vigilance Specialist, if applicable.

· Review of keywords for patient harm

· Assignment of reported problem code, resolution codes, hazards, hazardous situations product naming conventions, UDI, etc., per local procedures

· Completed evaluation process as per timelines.

· Document investigation summary.

· Peer review activity for evaluation work

· Product return determination

· Document investigation summary.

· Assist with customer response letters, as needed.

· Complaints closure.

· Keep abreast of changes in the process.

· Complete all needed records in a timely and accurate manner.

· Adherence to schedules, work plans, and performance requirements.

• To meet service level expectations and maintaining high quality delivery.
• Has clear understanding of KPIs.
• Lead experience in medical device compliant investigations

SKILLS REQUIRED:

• Basic understanding of CAPA, as well as global medical device regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, and ISO13485.
• Able to write effective Medical and Technical narratives regarding the complaints.
• Must have good computer skills.
• Able to think critically and ask pertinent questions to gather necessary information.
• Good problem solving and analytical skills.
• Lead experience in medical device compliant investigations

· Attention to detail.

· Works autonomously within established procedures and practices to meet complaint timeline requirements.

• Lead experience in medical device compliant investigations

CANDIDATE SPECIFICATIONS:

• Bachelor’s degree or Diploma in bio medical engineering, Pharma, Science, or related technical degree with 2-5 years of experience; OR: Bachelor’s degree or Diploma with 2 years of experience in a medical device or regulated industry.
• Medical Device or biomedical experience in undergraduate program or other related work experience preferred.