Regulatory Compliance Associate

Regulatory Compliance Associate

Finance and Operations Team - Full Time

On Site in Boise, Idaho

The Opportunity
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.

What You'll Do

• 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.

What You'll Need to Succeed

• 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.

Compensation & Perks

• $65,000 - $72,000 annual salary, commiserate on experience
• Company-Paid Health Insurance (medical/dental/vision/life)
  401(k) & Roth 401(k)
• No-Cost, In-House Preschool
• Casual Dress Code
• Flexible PTO

Who We Are:

Saalt empowers people to care for their periods in a healthy and sustainable way. We do this by creating high-performance products and stigma-breaking branding that engage customers and communities, pioneering the way to bring sustainable, clean period care to the mainstream consumer. Saalt invests in women and communities across the globe through period care donations, and by funding scholarships and life skills training to change generations.

As a certified B Corp, we strive to be the change we seek in the world, conduct business knowing that people and planet matter and aspire to use business as a force for good to benefit all. We create modern reusable period care without the toxins, the chemicals, and the wrappers you throw away every month. We commit to do more with less, make deliberate choices about our bodies, and believe everyone should know what their cervix is. Our growing team is based in beautiful Boise, Idaho.

Saalt is an equal opportunity employer. We welcome applicants of all backgrounds and do not discriminate based on race, color, religion, sex, national origin, age, disability, or any other protected status under applicable law.