Senior Regulatory Affairs Specialist

About the role

As the Senior Regulatory Affairs Specialist at LifeNet Health, 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.

Responsibilities

• Develop creative regulatory strategies for new product development teams.
• Plan and submit product dossiers for US and international regulatory approval.
• Evaluate the regulatory impact of post-approval design and manufacturing changes and develop submission plans that support business and registration continuity.
• Support the development and negotiation of appropriate marketing claims with commercial teams.
• Participate in continuous improvement initiatives, special projects, and process optimization efforts using LEAN principles.

Requirements

• 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.