Regulatory Affairs Associate

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

Responsible for the global coordination and the preparation of documents/packages for regulatory submissions. In this position you will also review and evaluate technical and scientific data and reports required for submission in support of global client's products.

Essential Duties and Responsibilities

• Supports regulatory project plan execution
• Maintain awareness of regulatory requirements and ensure continued learning
• Maintain regulatory files in a format consistent with requirements
• Participate as an active team member of project teams as required
• Compile and prepare responses to questions from regulatory authorities according to plan
• Edit and proofread regulatory documentation
• Assist in preparation and review of labeling, SOP's, and other departmental documents
• Compile under supervision regulatory documents for submission
• Track status and progress of regulatory documentation
• Understand Regulatory Affairs' position in small project teams

Qualifications

• Knowledge of regulations
• Scientific knowledge
• Administrative and project management skills
• Ability to contribute to multiple projects from a regulatory affairs perspective
• Ability to multitask and prioritize
• Interpersonal and communication skills
• Technical system skills (e.g. word processing, spreadsheets, databases, online research)
• Proofreading and editing skills

Education and/or Experience

• Bachelor's degree or country equivalent in a relevant scientific discipline
• Suitable candidates with a non-scientific degree may be accepted and undertake further training e.g. under an apprenticeship or similar post graduate qualification
• Regulatory experience preferably within a healthcare environment

Top three to five technical skill requirements

• Familiar with USA and OUS device regulations (specifically EU device regulations)
• Experience with RA strategy development
• Experience with working with Cross functional team members
• Experience with interaction with external Regulators (FDA, TUV)
• Experience with working with medical devices

Notes**:**

• Schedule (flexible)
• Remote position

VIVA is an equal opportunity employer. All qualified applicants have an equal opportunity for placement, and all employees have an equal opportunity to develop on the job. This means that VIVA will not discriminate against any employee or qualified applicant on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status