Compliance Specialist Job at Integrated Resources, Inc ( IRI ), Minneapolis, MN

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  • Integrated Resources, Inc ( IRI )
  • Minneapolis, MN

Job Description

Greetings

Hope everything is going well at your end!

This is SAVI from integrated resources (IRI), I am working as Delivery Lead at IRI

Quick Interview!

Assoc MDR-Vigilance Spec

Mounds View, MN Hybrid- 2 day onsite (Wed & Thu)

Duration: 24Months+

Fixed Pay

Must Have: Minimum Requirements

• Bachelor’s degree required

Top 3 things the manager is looking for:

MDR Experience

Previous healthcare experience

Med device company experience

Top 3 Tasks in Product for this role:

Review incoming complaints from the field

Go back out to the field for further information on complaints

File regulatory reports

Please let me know if you are available/interested so we can further discuss this position. Also email me your resume and contact number where I can call you. You can directly email me on my email address savi@irionline.com or you can give me a call at 732-707-5942

JOB DESCRIPTION

Top 3 things the manager is looking for:

MDR Experience

Previous healthcare experience

Med device company experience

Top 3 Tasks in Product for this role:

Review incoming complaints from the field

Go back out to the field for further information on complaints

File regulatory reports

Location: Mounds View, MN Onsite work Wednesday and Thursday.

Hours: 40

Responsibilities may include the following and other duties may be assigned.

• Monitors the company's drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse reports, participation in the resolution of any legal liability and in complying with government regulations.

• Ensures complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies.

• Review and analyze clinical databases for the extraction of ADE data and integrates the data to ensure the creation of a unified database consistent with the aims and purposes of ADE standardization and internalization as well as to ensure the accuracy and quality of safety summaries.

• Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.

Must Have: Minimum Requirements

• Bachelors degree required

• 0 years of experience required

--------------------------------------------------------

Template JD:

Responsibilities may include the following and other duties may be assigned. Monitors the company's drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse reports, participation in the resolution of any legal liability and in complying with government regulations. Ensures complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies. Review and analyze clinical databases for the extraction of ADE data and integrates the data to ensure the creation of a unified database consistent with the aims and purposes of ADE standardization and internalization as well as to ensure the accuracy and quality of safety summaries. Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects – from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education. DIFFERENTIATING FACTORS Autonomy: Entry-level individual contributor on a project or work team. Works with close supervision. Organizational Impact: Delivers work of limited Product, typically smaller, less complex projects or related activities. Innovation and Complexity: Identifies, defines and addresses problems that are not immediately evident but typically not difficult or complex. Makes minor changes in systems and processes to solve problems. Communication and Influence: Communicates primarily with internal contacts within immediate group. Contacts others to gather, confirm and convey information. Leadership and Talent Management: N / A – job at this level is focused on self-development. Required Knowledge and Experience: Requires broad theoretical job knowledge typically obtained through advanced education. Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A), 0 years of experience required.

Job Tags

Contract work, Immediate start,

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