Remote Regulatory Affairs Specialist – Global Compliance

Talent Reel; Minneapolis (MN); On-site; USD 90,000 - 130,000; Full time

Job summary

Talent Reel is seeking an Regulatory Affairs Specialist, International, to support global regulatory strategy, submissions, and compliance across U.S. and international markets. This role collaborates with R&D, Quality, and Marketing to ensure products meet regulatory requirements throughout their lifecycle.

The candidate will manage filings, STED documentation, and international registrations, while coordinating with customers and partners and ensuring ongoing compliance and audit readiness.

Qualifications

• Bachelor’s degree in a scientific, technical, or related field required.
• Regulatory Affairs Certification (RAC) from RAPS is a plus
• 2–5 years of experience in a regulated industry, preferably medical devices or combination products
• Understanding of regulatory history, guidelines, policies, and applicable product laws across domestic and international jurisdictions
• Strong technical writing skills and ability to produce clear regulatory documents

Responsibilities

• Prepare and submit regulatory filings for U.S. and international markets, including 510(k)s and Design Dossiers.
• Develop and maintain product Summary Technical Documentation (STED) to support global registrations.
• Coordinate international registration activities for customers and partners.
• Review quality records, preclinical data, and clinical materials for regulatory submissions.
• Manage routine annual regulatory requirements and registrations across multiple regions.
• Support Notified Body audit prep by compiling documents and tracking actions.

Skills

Technical writing

Regulatory knowledge

Communication skills

Cross-functional collaboration

Microsoft Office proficiency

Education

Bachelor’s degree in a scientific/technical field

MS or MBA is a plus

Tools

Microsoft Office Suite

Job description

Talent Reel is seeking an Regulatory Affairs Specialist, International, to support global regulatory strategy, submissions, and compliance across U.S. and international markets. This role collaborates with R&D, Quality, and Marketing to ensure products meet regulatory requirements throughout their lifecycle.

The candidate will manage filings, STED documentation, and international registrations, while coordinating with customers and partners and ensuring ongoing compliance and audit readiness.