Associate Medical Device Reporting/Vigilance Specialist
4 weeks ago
Associate Medical Device Reporting/Vigilance Specialist.
Length: 6-month
Pay Rate: ~$26.50 - $27.00/hr.
Location: Mounds View, MN OR Lafayette, MN
Education Required: Bachelor's Degree
Years’ Experience Required: 1+ years
Hours: 40hrs per week - 8am-5pm
Hybrid Role: 2-3 days in office
HM's Top Needs:
- Complaint handling &/or medical device experience would be a plus.
- Strong analytical skills.
- Strong communication skills
Responsibilities:
- Application of end-to-end complaint handling process with focus on product analysis and investigation summaries.
- Writing & reviewing investigation summaries that meet compliance requirements.
- Collaborating with key stakeholders involved in product analysis and investigation summaries.
Description:
Associate MDR/Vigilance Specialists are responsible for the intake, documentation, Medical Device Reporting, and investigation of complaints for Endoscopy products in accordance with applicable internal procedures (work instructions) and external requirements (regulations or guidance from all regulatory bodies).
A Day in the Life
Responsibilities may include the following and other duties may be assigned.
- Receive and assess product comments to determine need for complaint handling record.
- Document required information in Global Complaint Handling (GCH).
- Assess complaint file for missing required information. If information is missing, initiate attempts to gather information. Steps may include contacting:
- Field Personnel
- Health Care Providers
- Patients or other initial reporters
- Communicate with outside parties in a professional and customer-focused manner that is in following with our Mission and enhances the company brand.
- Evaluate incoming product events to determine MDR and Vigilance reporting eligibility.
- Initiate, complete regulatory reports for timely submission to FDA and other regulatory bodies.
- Determine if investigation is necessary. If investigation is necessary, determine:
- Potential cause and contributing factors to the alleged event.
- Device relationship.
- If formal device investigation is necessary.
- Summarize the results of any investigation.
- Escalate complex issues to management.
- Execute other projects as assigned.
Qualifications
Must Have: Minimum Requirements
- Bachelor's degree with 0 years’ experience in healthcare or medical device/pharmaceutical industry in safety or clinical data evaluation
Nice to Have
- High level of computer proficiency (e.g. Microsoft Office, SAP, Siebel, Oracle Clinical, etc.)
- 0-2 years’ experience in healthcare or medical device/pharmaceutical industry in safety or clinical data evaluation
- Degree in Health Care, Sciences, or Bio-Medical Engineering
- Strong attention to detail
- Knowledge of basic anatomy, physiology, and medical terminology
- Knowledge of:
- 21CFR, Section 820, Quality System Regulation
- 21CFR Section 803, Medical Device Reporting
- ISO 13485, Quality Systems, Quality Management Systems
- 45CFR, Parts 160 and 164, Patient Privacy Rule- HIPPA Regulations
- AIMD Directive: 90/385/EEC
- IVD Directive: 98/97/EC
- MDD Directive (Council Directive 93/42/EEC for Medical Devices)
- PC 1998-783 - Canadian Medical Device Regulation (CMDR)
- Complaint handling experience or customer service/technical support experience (0-2 years)
- Strong analytical skills (problem solving, critical thinking)
- Excellent communication skills (oral and written), with strong organizational and analytical skills
- Ability to work independently or in a team setting
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