Regulatory Support Specialist - Medical Devices (Onsite MN)

HCLTech; Mounds View (MN); On-site; USD 22,041 - 24,796; Full time

Benefits offered by this job

Medical insurance

Dental insurance

401(k) retirement plan

Paid time off

Paid holidays

Job summary

A leading technology company in Mounds View, MN is seeking a Technical Support Specialist to ensure regulatory compliance and manage medical device reporting. The ideal candidate will hold a Bachelor's degree, have strong computer proficiency and 0-2 years of relevant experience in the healthcare or medical devices field. Responsibilities include monitoring compliance, interfacing with contacts, and ensuring accurate reporting. Competitive pay starting from $16/hour, along with comprehensive benefits and growth opportunities.

Qualifications

• 0-2 years of experience in healthcare or medical device/pharmaceutical industry in safety or clinical data evaluation.
• Medical device industry experience preferred.
• Knowledge of basic anatomy and physiology.

Responsibilities

• Apply policies and procedures to comply with FDA and OUS regulations.
• Monitor the company's drug or medical devices surveillance program.
• Ensure accurate and timely submission of Medical Device Reports.
• Interface with internal and external contacts for complaint information.

Skills

Computer proficiency

Strong communication skills

Attention to detail

Education

Bachelor of Science degree

Degree in nursing, biology/pre-med, or biomedical engineering

Tools

Microsoft Office

SAP

Oracle Clinical

Job description

A leading technology company in Mounds View, MN is seeking a Technical Support Specialist to ensure regulatory compliance and manage medical device reporting. The ideal candidate will hold a Bachelor's degree, have strong computer proficiency and 0-2 years of relevant experience in the healthcare or medical devices field. Responsibilities include monitoring compliance, interfacing with contacts, and ensuring accurate reporting. Competitive pay starting from $16/hour, along with comprehensive benefits and growth opportunities.