Regulatory Affairs Specialist

AT LIFENET HEALTH, YOU ARE THE ADVANTAGE

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. Together , we are united by a mission greater than ourselves, a purpose rooted in healing.

ABOUT THIS JOB

Location :

Virginia Beach, VA (Concert)

Department :

Regulatory Affairs Schedule :

Monday-Friday (8:15AM

• 5:00PM)

Clinical Status :

Non-Clinical

HOW YOU'LL MAKE AN IMPACT

As a Regulatory Affairs Specialist, you'll play a vital role in advancing our mission. In this position, you'll be responsible for supporting 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. Your work will have purpose every single day, contributing directly to life-changing outcomes.

WHAT YOU'LL DO

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. 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:

Research jurisdictional requirements and options for regulatory submissions, approval pathways, and compliance activities. Maintains regulatory documentation, assisting 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.

WHAT YOU'LL BRING

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

Key Knowledge, Skills, & Abilities:

Technical Writing:

Applies plain-language principles and structured writing techniques to present technical information clearly and accurately to both technical and non-technical audiences.

Time Management:

Able to prioritize multiple, competing priorities and manage time/workload. Demonstrated ability to effectively prioritize and juggle multiple time sensitive projects, multi-task, identify project interdependences and potential risks/pitfalls.

Communication Skills:

Excellent communication skills; ability to communicate and build relationships with all professionals at different levels within the organization Attention to

Detail:

Able to perform tasks thoroughly and with care; checks work to ensure high degree of accuracy/completeness and early/on-time delivery

Teamwork:

Ability to mentor junior staff and lead team. Ability to be collaborative and work as part of a team to resolve issues, complete tasks, and meet business needs. Proficient in

MS Office:

PowerPoint, Excel, Word, Outlook, Microsoft Suite, as position requires

WHY JOIN LIFENET HEALTH

When you join LifeNet Health, you're not just taking a job, you're joining a mission-driven community dedicated to making a global impact through regenerative medicine. You'll be part of a workplace that values authenticity, collaboration, and the drive to make a difference . We recognize that great work happens when people feel supported. That's why our total rewards package is designed to help you thrive both professionally and personally. Here's how we support

YOU:

Affordable Medical, Dental, and Vision Coverage

• Comprehensive care that won't break the bank. Profit Sharing Plan
• Share in the success you help create. 403(b) Retirement Plan
• Invest in your future with confidence. Paid Parental Leave
• 6 weeks to bond with your newest family member. Corporate Sponsored Events
• Celebrate milestones and build connections. Generous Paid Time Off
• Because balance matters: 18 vacation days (based on position, tenure, and state laws) 9 sick days (subject to local and state regulations) 9 holidays (7 standard + 2 floating) Flexible Work Program
• For approved roles, how and where you perform best. Tuition reimbursement
• We invest in your growth and education. Career & Leadership Development
• Expand your impact and potential. Wellness Program
• Prioritize your health with holistic resources. Employee Assistance Program (EAP)
• Support for you and your household. Incredible teammates
• Collaborate with passionate, dedicated professionals.

Note:

All benefits are subject to eligibility requirements and may be modified at any time, with or without notice, unless otherwise required by law. This job posting does not constitute an employment contract and does not alter the "at-will" nature of employment at LifeNet Health.

COMPENSATION

Salary Range:

$ 65,972

• $87,962/ annually Final compensation will be based on factors such as geographic location, qualifications, and prior relevant experience.

Actual compensation may be higher based on the successful candidate's knowledge and relevant experience.

EQUAL OPPORTUNITY EMPLOYER

LifeNet Health is an equal opportunity employer. We consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other legally protected status. As part of our commitment to safety, we maintain a drug-free workplace and conduct pre-employment substance abuse screening.