Job Description

Full job description

Job Title: Assoc MDR/Vigilance Specialist - Exempt

Job Description

We are seeking a dedicated and detail-oriented Associate MDR/Vigilance Specialist to join our team. This role involves working on-site in Mounds View, MN for 2-3 days a week, with core hours from 9am to 3pm, Monday through Friday. The candidate will be responsible for monitoring and maintaining the company's drug or medical devices surveillance program, ensuring compliance with regulatory requirements, and supporting various project initiatives.

Responsibilities

• Monitor the company's drug or medical devices surveillance program, including intake protocol development, evaluation, processing, and follow-up on adverse reports.
• Ensure 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 integrate the data to ensure the creation of a unified database consistent with ADE standardization and internalization.
• Act as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.
• Deliver and manage projects assigned, working with other stakeholders to achieve desired results.
• Collaborate with the team to support project initiatives and contribute to the overall goals.

Essential Skills

• Undergraduate degree is required.
• 1-3 years of experience in the medical device industry or a regulated work environment.
• Experience with US Regulatory requirements and MDR compliance.
• Medical background or experience with medical device manufacturing.
• Strong understanding of cardiovascular devices is beneficial.

Additional Skills & Qualifications

• Experience with database management and clinical data analysis.
• Excellent communication skills for internal and external collaboration.
• Ability to make minor changes in systems and processes to solve problems.
• Self-development focus with the ability to work under close supervision.

Work Environment

The role is based in Mounds View, MN, requiring on-site presence 2-3 days a week with core hours from 9am to 3pm, Monday to Friday. The work environment is highly regulated, focused on medical devices, and requires adherence to strict compliance and reporting standards. Collaborative teamwork and project management are key components of this role.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

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