Assoc MDR/Vigilance Spec - Exempt

Job Description

Job Description

JOB DESCRIPTION

HM's Top Needs:

1. Past MDR Experience

2. Excellent organizational and time management skills

3. Strong critical thinking skills

We are seeking an Associate MDR Specialist to support day-to-day Medical Device Report (MDR) complaint handling activities. This role is responsible for reviewing and processing complaint records while ensuring compliance with regulatory requirements, internal procedures, and quality standards. The ideal candidate is detail-oriented, able to manage multiple priorities in a fast-paced environment and possesses strong analytical and written communication skills. Experience working in a regulated environment is preferred, and a clinical background (such as a Registered Nurse or other healthcare professional) or a degree in Biomedical Engineering is considered a strong asset.

Education Required: Bachelors

Years Experience Required: 1-3 years

Will the contractor be working 40 hours a week? If not, weekly estimate? Yes, 40 hours per week

Work Location: Hybrid. Candidates should be local to the Mounds View, MN office and able to work onsite four days per week and may work remotely one day per week.

Do they need to be local to any MDT office and if so where? Mounds View

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 scope, 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.