Technical Support Specialist

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

HCLTech is looking for a highly talented and self- motivated [Registered Nurse] to join it in advancing the technological world through innovation and creativity.

Job Title

Job Title: [Technical Support Specialist

Job ID

Job ID: (72533)

Position Type

Position Type: Full-time

Location

Location: Mounds View, MN (Onsite)

Role / Responsibilities

• Apply policies and procedures to comply with FDA and OUS regulations.
• Monitors 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.
• Ensures 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.
• Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements
• Other duties as assigned.

Qualifications & Experience

• Bachelor of science degree
• 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

Desired Qualifications

• Degree in nursing, biology/pre‑med or pre‑vet, or biomedical 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

Pay and Benefits

Pay Range Minimum: $16 per hour

Pay Range Maximum: $18 per hour

HCLTech is an equal opportunity employer, committed to providing equal employment opportunities to all applicants and employees regardless of race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical disability or genetic information, military or veteran status, or any other protected classification, in accordance with federal, state, and/or local law. Should any applicant have concerns about discrimination in the hiring process, they should provide a detailed report of those concerns to [e-mail] for investigation.

A candidate’s pay within the range will depend on their skills, experience, education, and other factors permitted by law. This role may also be eligible for performance-based bonuses subject to company policies. In addition, this role is eligible for the following benefits subject to company policies: medical, dental, vision, pharmacy, life, accidental death & dismemberment, and disability insurance; employee assistance program; 401(k) retirement plan; 10 days of paid time off per year (some positions are eligible for need-based leave with no designated number of leave days per year); and 10 paid holidays per year

How You’ll Grow

At HCLTech, we offer continuous opportunities for you to find your spark and grow with us. We want you to be happy and satisfied with your role and to really learn what type of work sparks your brilliance the best. Throughout your time with us, we offer transparent communication with senior-level employees, learning and career development programs at every level, and opportunities to experiment in different roles or even pivot industries. We believe that you should be in control of your career with unlimited opportunities to find the role that fits you best.