Regulatory Affairs Specialist (10322-2026443)

About the role

Every day, you help us to save lives, restore health, and bring hope to patients and families around the world. At LifeNet Health, we cultivate growth, innovation, and collaboration, where your contributions drive solutions that benefit humanity.

Location

Virginia Beach, VA (Concert)

Department

Regulatory Affairs

Schedule

Monday-Friday (8:15AM – 5:00PM)

How you’ll make an impact

In this position, you’ll play a vital role in advancing our mission. You’ll support the organization’s compliance with global regulatory requirements within the medical device, biologics, and tissue combination product industry. This role is responsible for monitoring and maintaining documentation of applicable laws and regulations; supporting the development and execution of regulatory strategies for new products and market expansions; preparing and submitting of dossiers for regulatory approval; evaluating change requests for impact on regulatory submissions; reviewing product labeling and promotional materials to ensure regulatory compliance; and responding to internal and external requests for regulatory information.

Submissions

• Plans, organizes, and submits dossiers for regulatory approval.
• Evaluates the potential impact on submissions from new guidance and regulations.
• Tracks the status of applications under regulatory review and provides updates to management and applicable stakeholders.
• Captures and coordinates the development of timely responses to regulatory authorities’ queries and leads interactions with regulatory authorities during the review process.

Regulatory Strategy and Design Control

• Provides regulatory input and guidance on global regulatory requirements to product development teams.
• Evaluates product classifications and submission pathways across global markets, develops and implements regulatory filing strategies, and communicates key submission milestones and status updates.
• Serves as regulatory lead on cross-functional product development teams.
• Reviews and provides feedback on documentation for design review, evaluates technical documentation for regulatory submissions to ensure compliance with applicable regulations and standards, and collaborates with the product development team to address regulatory authority’s queries, deficiencies, and submission-related requirements.

Change Management

• Participates in the review of change requests to determine the impact on regulatory submissions.
• Communicates submission filing status and relevant milestones.
• Prepares and submits post-market change notifications to applicable regulatory authorities and/or external partners.

Compliance

• Researches jurisdictional requirements and options for regulatory submissions, approval pathways, and compliance activities.
• Maintains regulatory documentation, assists with regulatory submissions, registrations, licenses, and listing.
• Partners with Regulatory and Quality teams to evaluate the impact of regulatory changes, support the development and implementation of regulatory procedures, and ensure product labeling and promotional materials comply with applicable regulations and guidance.
• Maintains regulatory information within internal systems and regulatory authority databases and prepares regulatory documentation and certifications to support internal and external requests.

Minimum Requirements

• Bachelor’s Degree
• Three (3) Years – Regulatory experience in medical device or similar regulated industry

Preferred Experience/Skills/Certifications

• Bachelor’s Degree – Engineering, Chemistry, Biology, Regulatory Affairs or other science-related discipline
• RAPS – Regulatory Affairs Certification
• Five (5) Years – Regulatory experience in medical device or similar regulated industry

Why Join LifeNet Health

• Note: All benefits are subject to eligibility requirements and may be modified at any time, with or without notice, unless otherwise required by law.

Compensation

Salary Range: $65,972 - $87,962/annually