Regulatory Affairs Specialist

A company is looking for a Regulatory Affairs - Design Control Specialist.

Key Responsibilities

Establish project-specific technical file deliverable lists aligning with internal SOPs and regulatory standards

Coordinate deliverables across teams and ensure compliance with design control expectations

Assist with international regulatory submissions and perform quality-related duties as assigned

Required Qualifications

5+ years of Quality Systems experience and Software as a Medical Device (SaMD) experience

3+ years in a project management or technical leadership role

Experience in a regulated agile development environment

Familiarity with global medical device regulations and standards

Demonstrated understanding of ISO 13485, ISO 14971, and IEC 62304