Regulatory Affairs Specialist

Position Title: Regulatory Affairs Specialist About This Job Location: Virginia Beach, VA (Concert) Department: Regulatory Affairs Schedule: Monday-Friday (8:15 AM to 5:00 PM) Clinical Status: Non-Clinical How You'll Make an Impact As a Regulatory Affairs Specialist, you will play a vital role in advancing our mission. You will be responsible for supporting the organization’s compliance with global regulatory requirements within the medical device, biologics, and tissue combination product industry. This role monitors and maintains documentation of applicable laws and regulations; supports the development and execution of regulatory strategies for new products and market expansions; prepares and submits dossiers for regulatory approval; evaluates change requests for impact on regulatory submissions; reviews product labeling and promotional materials to ensure regulatory compliance; and responds to internal and external requests for regulatory information. 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: 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. What You'll Bring Minimum Requirements: Bachelor’s Degree Three (3) years of regulatory experience in medical device or similar regulated industry Preferred Experience/Skills/Certifications: Bachelor’s Degree in Engineering, Chemistry, Biology, Regulatory Affairs or other science‑related discipline RAPS Regulatory Affairs Certification Five (5) years of 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. Heres 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. Equal employment opportunity, including veterans and individuals with disabilities. PI285067116 #J-18808-Ljbffr