Regulatory Affairs Associate

Job Description

Overview –

Responsibilities for this role include reviewing product events from a variety of sources to determine the complaint status and create the complaint record in the complaint handling system. This role is also responsible for determining the regulatory reporting status, completing the regulatory report, and ensuring timely submission. Responsibilities of this role also include conducting follow-up with internal and external contacts to ensure complete complaint information is obtained as well as evaluating incoming information for Medical Device Reporting and Vigilance Reporting eligibility.

Responsibilities –

1. Reviewing potential complaints and making complaint decisions.

2. Making reportability decisions and submitting regulatory reports.

3. Performing follow-up for required information to field representatives and Health Care Professionals.

Top 3 things

1. Strong attention to detail

2. Strong analytical skills (problem solving critical thinking)

3. Strong writing skills

Qualification & Requirements –

Requires a Baccalaureate degreeCompany Description

Select Source International (SSI) is a distinguished staffing company with nearly 25 years of experience, renowned for delivering top-tier workforce solutions encompassing staffing, recruiting, and managed services. As a proud supplier, we bring a wealth of expertise and best-in-business differentiators to comprehensively support your diverse workforce needs.

Based in Minneapolis, Minnesota, USA, SSI has established itself as a global leader, serving a broad clientele across industries with unwavering dedication and excellence. SSI is ISO 9001, 14001, and Soc2 Type2 certified, underscoring our commitment to quality and security. We have garnered numerous sustainability and supplier diversity awards, further validating our industry-leading capabilities

Full-time