Regulatory Affairs Specialist

2h2 hours ago

LifeNet Health

Virginia Beach, US · Full-time · $65,972 – $87,962

About this role

At LifeNet Health, you are the advantage in a mission-driven organization that saves lives, restores health, and brings hope to patients and families worldwide. As a Regulatory Affairs Specialist, you will support the organization's compliance with global regulatory requirements within the medical device, biologics, and tissue combination product industry.

Your day-to-day work involves monitoring and maintaining documentation of applicable laws and regulations, preparing and submitting dossiers for regulatory approval, and evaluating change requests for impact on regulatory submissions. You will also review product labeling and promotional materials to ensure regulatory compliance, and respond to internal and external requests for regulatory information.

You will collaborate closely with cross-functional product development teams, providing regulatory input and guidance on global requirements. As the regulatory lead on these teams, you will evaluate product classifications and submission pathways across global markets, develop filing strategies, and communicate key milestones to stakeholders.

This role offers the opportunity to contribute directly to life-changing outcomes, with work that has purpose every single day. You will grow your expertise in regulatory strategy, design control, and change management within a culture that cultivates growth, innovation, and collaboration.

Requirements

Experience supporting compliance with global regulatory requirements in the medical device, biologics, or tissue combination product industry.
Ability to prepare and submit dossiers for regulatory approval and track application status.
Knowledge of regulatory strategy and design control processes for product development.
Experience evaluating product classifications and submission pathways across global markets.
Skill in reviewing product labeling and promotional materials for regulatory compliance.
Ability to evaluate change requests for impact on regulatory submissions.
Experience responding to internal and external requests for regulatory information.
Proficiency in maintaining regulatory documentation and assisting with registrations, licenses, and listings.

Responsibilities

Plan, organize, and submit dossiers for regulatory approval, tracking application status and providing updates to management and stakeholders.
Evaluate the impact of new guidance and regulations on submissions, and coordinate timely responses to regulatory authorities' queries.
Provide regulatory input and guidance on global regulatory requirements to product development teams.
Evaluate product classifications and submission pathways across global markets, developing and implementing regulatory filing strategies.
Serve as regulatory lead on cross-functional product development teams, reviewing design documentation and technical documentation for compliance.
Participate in the review of change requests to determine impact on regulatory submissions, and prepare post-market change notifications.
Research jurisdictional requirements for regulatory submissions, approval pathways, and compliance activities.
Maintain regulatory documentation, assist with submissions, registrations, licenses, and listings, and partner with Regulatory and Quality teams.

Benefits

Mission-driven work that directly contributes to saving lives and restoring health.
Culture of growth, innovation, and collaboration where your contributions drive solutions that benefit humanity.
Purpose rooted in healing, united by a mission greater than ourselves.
Non-clinical role with a consistent Monday-Friday schedule (8:15 AM – 5:00 PM).