Medical Device Reporting Specialist

Atlanta, GA 30341 (Onsite)

Fulltime/Permanent

• 2+ years of experience in medical device product quality complaints management / post market surveillance

• Knowledge of complaints management in medical device industry

• Good understanding on ISO 13485 or any other ISO/GxP Standard/Guidelines

• Able to write effective Medical and Technical narratives regarding the complaints

• Associate will be trained on client tools, platform, products, SOPs and templates

• Perform complaint decision trees and Vigilance Reporting as required

• Perform Reportability check of a complaint

• Perform clinical assessment of complaint

• Draft, review and submit vigilance reports

• Support regulatory and HA inquiries

• 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.

• Attention to detail.

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

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.