Senior Regulatory Affairs Specialist
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 organization’s 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.
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
- Preferred: Master's Degree
- Preferred: 2 years of experience with collagen or animal-derived medical devices
- An agile learning mindset that thrives on finding creative solutions to complex problems.
- An analytical curiosity to our existing technical workflows, actively looking for compliant innovative ways to elevate them.
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.