Regulatory Compliance Associate

Saalt•Boise, ID

2d•Onsite

About The Position

Saalt is seeking a full-time Regulatory Compliance Associate with hands-on experience in an ISO 13485 environment. This role will help maintain Saalt’s Quality Management System, support key compliance projects, and ensure smooth day-to-day quality operations in the warehouse. You will collaborate with outside consultants and internal leadership for regulatory-facing activities, while taking ownership of execution and implementation. This is an ideal role for someone with at least two years of ISO 13485 experience who is motivated, detail-oriented, and eager to grow in a mission-driven company.

Requirements

Bachelor’s Degree or equivalent work experience.
Minimum of two years’ experience in a quality role within an ISO 13485 environment (medical device preferred).
Working knowledge of ISO 13485 standards and Quality System requirements.
Strong organizational and time management skills.
Ability to problem-solve, adapt quickly, and work independently.
Effective written and verbal communication skills.
High integrity and collaborative mindset.
Be able to lift and carry 50 lbs.

Responsibilities

Maintain, update, and support Saalt’s Quality Management System under ISO 13485.
Conduct gap analyses for suppliers and support them in achieving ISO 13485 compliance.
Support OSHA compliance and safety processes for Saalt’s new warehouse operations.
Assist with internal audits, trainings, and day-to-day QMS activities (CAPAs, change control, training records, document control, etc.).
Provide quality support for warehouse activities such as kitting and wholesale order fulfillment.
Partner with consultants and leadership for external audits, certifications, and escalated regulatory issues.
Perform monthly TOP (top of production) audits on product to ensure quality standards and vendor compliance.
Contribute to Quality Management Reviews by compiling documentation and data.
Serve as the primary escalation point for regulatory reporting issues, coordinating resolution across internal stakeholders and external service providers.
Translate complex regulatory developments into business-relevant guidance and communications.