Senior Regulatory Affairs Specialist

LifeNet Health; Virginia Beach (VA); On-site; USD 90,000 - 130,000; Full time

Job summary

LifeNet Health’s Regulatory Affairs team seeks a Senior Regulatory Affairs Specialist in Virginia Beach to drive global regulatory strategy and timely submissions for medical devices and biologics.

You will collaborate with cross-functional teams to ensure compliance, plan US and international dossiers, and navigate post-approval changes while supporting marketing claims. This role offers impactful work in regenerative medicine.

Qualifications

• 5 years of regulatory experience in medical device or similar regulated industry.
• 2 years of experience with high-risk (e.g., Class 3/PMA) regulated products in the US, EU, and other geographies.

Responsibilities

• Develop creative regulatory strategies for new product development teams.
• Plan and submit product dossiers for US and international regulatory approval.
• Evaluate post-approval design and manufacturing changes and develop submission plans.
• Support the development and negotiation of appropriate marketing claims with commercial teams.
• Lead continuous improvement projects using LEAN principles.

Skills

Regulatory strategy

Regulatory approvals

Cross-functional collaboration

Education

Bachelor's Degree

Tools

Regulatory submissions software

Job description

Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

PrimaryLocation: Virginia Beach, VA, United States

StudyLevel: Bachelor's Degree

RequisitionType: Exempt (EX)

Description

HOW YOU WILL MAKE AN IMPACT

At LifeNet Health, as the Senior Regulatory Affairs Specialist, you will make an impact by leveraging your expertise, collaboration, and commitment to excellence to help advance our mission of Saving Lives, Restoring Health, and Giving Hope. Through your daily work, you will contribute to innovative solutions, operational excellence, and meaningful outcomes that support donors, patients, healthcare providers, and our communities. Whether driving strategic initiatives, improving processes, supporting customers, advancing research, developing talent, or ensuring quality and compliance, your contributions will help strengthen our ability to transform lives and shape the future of regenerative medicine.

WHAT YOU WILL DO

This role supports the organizations global regulatory strategy and compliance within the medical device, biologics, tissue, and combination product industry. This role involves developing creative regulatory strategies for new product development teams; planning and submission of product dossiers for US and international regulatory approval; evaluating the regulatory impact of post-approval design and manufacturing changes and developing submission plans that support business and registration continuity; and supporting the development and negotiation of appropriate marketing claims with commercial teams. continuous improvement initiatives, special projects, and process optimization efforts using LEAN principles.

WHAT YOU WILL BRING

• 5 years of regulatory experience in medical device or similar regulated industry
• 2 years of experience with high-risk (e.g., Class 3/PMA) regulated products in the US, EU, and other geographies

Pay Transparency Statement

The salary range displayed represents the national base salary range for this position and is provided in good faith to support pay transparency. For positions located in designated higher-cost labor markets, a geographic pay adjustment may apply above the posted range for eligible positions according to LifeNet Health's current policy. Final compensation will be determined based on factors such as work location, relevant experience, skills, qualifications, and internal equity. Total compensation may also include bonuses, benefits, and other rewards that are not reflected in the posted salary range.

LifeNet Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability, veteran status, genetic information, sexual orientation, gender identity, or any other protected status under applicable law.

About LifeNet Health

At LifeNet Health, YOU are the advantage.

Every day, you empower us to save lives, improve health outcomes, and bring hope.

LifeNet Health is a nonprofit global leader in regenerative medicine that honors the gift of donation by advancing organ transplantation, tissue engineering, and biologic solutions that help save lives, restore health, and give hope. As one of the world's most trusted providers of transplant solutions, LifeNet Health partners with healthcare providers and researchers around the globe to deliver innovative therapies that improve patient outcomes and transform lives.

At LifeNet Health, we cultivate growth, innovation and collaboration, where your contributions drive solutions that benefit humanity. Our passionate team advances regenerative medicine while fostering a sense of belonging, authenticity, and dedication. We offer best-in-class benefits that provide stability, personal growth, and peace of mind, empowering you to make a difference.

Together we share a purpose beyond profit, united by a collective commitment to healing.

Equal employment opportunity, including veterans and individuals with disabilities.

PI287554490