Regulatory Manager at XVIVO in Denver, Colorado

Regulatory Manager

Our client, XVIVO, is seeking a Regulatory Manager to support US regulatory activities and ensure compliance across the full product lifecycle. Founded in 1998 in Sweden, XVIVO is a global medical technology company dedicated to extending the life of all major organs, enabling transplant teams to save more lives. Through their advanced perfusion technologies and innovative solutions, XVIVO empowers leading clinicians and researchers to push the boundaries of what is possible in transplantation. Their systems are designed not only to improve transplant outcomes but also to streamline workflows for surgical teams and enhance patients' long-term quality of life. XVIVO's mission is simple but powerful: no one should die waiting for an organ. Joining XVIVO means becoming part of a purpose-driven organization where your work directly contributes to life-saving advancements and meaningful impact on a global scale.

About The Role

As Regulatory Manager, you will play a key role in overseeing regulatory activities for the US market. You will ensure that products meet all applicable regulatory requirements while supporting product development, clinical activities, and commercialization. We expect you to serve as a key liaison with regulatory authorities and collaborate closely with cross-functional teams to drive compliance and efficiency. This role is based in Golden, CO, and reports directly to the Quality & Regulatory Director. Your responsibilities include:

• Lead the preparation and submission of regulatory filings for the US market (e.g., IDEs, PMAs, 510(k)s)
• Provide regulatory guidance throughout the product lifecycle, including clinical development, design updates, labeling, and post-approval changes
• Ensure accuracy and compliance in product labeling, IFUs, marketing claims, and promotional materials
• Ensure adherence to the quality management system and applicable SOPs
• Oversee safety reporting and complaint handling for investigational products in accordance with applicable regulations
• Identify and communicate regulatory requirements and support updates to ensure continued product and legal compliance
• Collaborate closely with R&D, Clinical, Quality, Manufacturing, and Commercial teams to integrate regulatory requirements into development and go-to-market strategies
• Act as the primary point of contact with regulatory authorities on behalf of Xvivo

What We Expect from You

• Bachelor's degree
• Min. 3 years of experience in a similar regulatory role within the medical device industry
• Experience working with and communicating directly with regulatory authorities
• Ability to work in a dynamic environment and adapt to change
• Strong collaboration skills and experience working cross-functionally in a global organization
• A proactive and team-oriented mindset, with a willingness to support colleagues across regions
• Proficiency in MS Office 365 suite and various business software (e.g., ERP, CRM)

What We Offer

• The opportunity to contribute to life-saving medical technology and make a real difference for patients worldwide
• An opportunity to be a part of a truly innovative and forward-thinking international company
• Salary range: $110,000-$140,000, and a Short-Term Incentive Program
• Comprehensive benefits package: Medical, dental, vision, short- and long-term disability, and life insurance, 401(k) with company match, Flexible time off and sick days, Paid maternity, paternity, and adoption leave

Equal Opportunity Employer

XVIVO is an equal opportunity employer and is committed to building an inclusive workplace. We consider all qualified applicants without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, disability, or veteran status.