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Medical Device Safety Associate
2 months ago
In this exciting position as a Regulatory Compliance Specialist, you will have the responsibility and authority to document and evaluate product feedback and product analysis results for company products to determine complaint status and regulatory reporting status in conjunction with US and OUS regulatory guidelines.
Key Responsibilities:
- Apply policies and procedures to comply with FDA and OUS regulations.
- Monitor the company's drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse event reports, complying with government regulations.
- Evaluate incoming information to determine Medical Device Reporting and Vigilance reporting eligibility.
- Ensure complete, accurate, and timely submission of Medical Device Reports (MDRs), Vigilance Reports (VR) Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies.
- Interface and collaborate with internal and external contacts to ensure appropriate collection of complaint information in an efficient and customer-focused manner.
- Maintain awareness of new products, government regulations, and requirements.
- Act as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.
Requirements:
- Bachelor's degree in a relevant field.
- High level of computer proficiency (e.g., Microsoft Office, SAP, Siebel, Oracle Clinical, etc).
- 0-2 years of experience in healthcare or medical device/pharmaceutical industry in safety or clinical data evaluation.
Preferred Qualifications:
- Degree in Health Care, Sciences, or Bio-Medical Engineering.
- Medical device industry experience.
- Strong verbal and written communication skills.
- Knowledge of basic anatomy and physiology.
- Strong attention to detail.
- High level of computer proficiency.