Global Regulatory Affairs Associate — Remote & Flexible

viva; United States; Remote; USD 85,000 - 125,000; Full time

Benefits offered by this job

Flexible schedule

Remote position

Job summary

VIVA seeks a Regulatory Affairs professional to coordinate global submissions, review technical data, and prepare documentation for regulatory authorities. The role supports project plans, maintains regulatory files, and collaborates with cross‑functional teams to ensure compliance of healthcare products.

The candidate will edit and proofread documents, assist with labeling and SOPs, and track submission status, contributing to successful regulatory outcomes across multiple projects.

Qualifications

• Knowledge of regulations and regulatory requirements across jurisdictions
• Scientific background relevant to healthcare devices or products
• Administrative and project management capabilities
• Ability to contribute to multiple projects from regulatory perspective
• Strong multitasking and prioritization
• Effective interpersonal and communication skills
• Proficiency with word processing, spreadsheets, databases, and online research
• Proofreading and editing of regulatory documents

Responsibilities

• Coordinate and prepare regulatory submissions and documents
• Support regulatory project plan execution and maintain files
• Review and evaluate technical data for submissions
• Prepare responses to regulatory authorities as needed
• Edit and proofread regulatory documents and labeling
• Collaborate with cross-functional teams on regulatory affairs
• Track status of regulatory documentation and milestones
• Interact with external regulators (FDA, others) as needed
• Understand RA role within small project teams

Skills

Regulatory knowledge

Scientific knowledge

Administrative & project management

Multitasking & prioritization

Interpersonal communication

Technical skills

Proofreading & editing

Education

Bachelor's degree in a relevant scientific discipline

Alternative: non-scientific degree with training/apprenticeship

Job description

VIVA seeks a Regulatory Affairs professional to coordinate global submissions, review technical data, and prepare documentation for regulatory authorities. The role supports project plans, maintains regulatory files, and collaborates with cross‑functional teams to ensure compliance of healthcare products.

The candidate will edit and proofread documents, assist with labeling and SOPs, and track submission status, contributing to successful regulatory outcomes across multiple projects.