Senior Quality and Regulatory Affairs Manager

Company: Sky Mavis
Location: San Diego
Posted on: February 1, 2025

Job Description:

About Truvian:Truvian is a fast-paced, innovative healthcare company revolutionizing blood testing at the intersection of diagnostics and consumer tech. Our proprietary, automated benchtop diagnostic system aims to deliver lab-accurate results in just 30 minutes, using a small blood sample. Truvian is committed to making routine health testing accessible, affordable, and actionable, empowering individuals with health information. With a mission-driven culture of innovation and teamwork, we strive to disrupt healthcare for the better.Job Summary:The Senior Quality and Regulatory Affairs Manager will oversee and manage Truvian's regulatory submissions and registrations, ensuring compliance with U.S. FDA regulations and global requirements. This role includes crafting regulatory strategies, managing submissions for global markets, and ensuring alignment with corporate goals and timelines. The ideal candidate is a detail-oriented leader with experience in in-vitro diagnostics (IVD) and CLIA Waivers, capable of navigating complex regulatory landscapes to enable Truvian's growth and product launches.Key Responsibilities:

• Develop and execute regulatory strategies and timelines supporting global commercialization plans.
• Serve as a regulatory representative on cross-functional project teams, providing advanced guidance on regulations and technical guidelines.
• Prepare, review, and manage technical documentation for regulatory submissions, including 510(k)s, pre-submission packages, and international registrations.
• Lead the submission process for regulatory approvals in the U.S. and global markets, including CE Mark/IVDR compliance.
• Monitor and communicate updates on regulations, standards, and guidance documents, ensuring Truvian's compliance.
• Review product changes to assess regulatory implications and maintain regulatory compliance.
• Advise senior management on significant regulatory issues or developments and recommend actionable solutions.
• Collaborate with product development teams to align technical activities with regulatory requirements.
• Support the review and approval of product labeling, advertising, and promotional materials.
• Build and maintain strong relationships with regulatory agencies, international distributors, and cross-functional teams.Qualifications:
• Education: Bachelor's degree in life sciences (required); master's degree preferred.
• Experience: At least 7 years in regulatory affairs, with a focus on in-vitro diagnostics and CLIA Waiver products.
• Strong technical writing skills and the ability to create clear, concise regulatory documentation.
• Demonstrated success in preparing and submitting regulatory filings, including 510(k)s, CLIA Waivers, and international product registrations.
• Deep knowledge of FDA regulations, IVD development processes, and global regulatory landscapes.
• Excellent project management, organizational, and problem-solving skills.
• Ability to work independently, take initiative, and manage multiple priorities under tight deadlines.
• Outstanding interpersonal and communication skills, with the ability to lead cross-functional teams and drive change.Why Join Truvian?
• Be part of a mission-driven team dedicated to disrupting healthcare with innovative solutions.
• Thrive in a dynamic environment that values fresh ideas, collaboration, and rapid execution.
• Enjoy generous benefits, including medical, dental, vision, 401(k), flexible PTO, paid parental leave, and wellness perks like an on-site gym, healthy snacks, and a farm-to-table restaurant.Salary Range: $126,000 - $172,000 annuallyFinal salary decisions are based on qualifications, experience, and internal equity.Physical Requirements:
• Ability to lift and move items up to 25 lbs. regularly and 75 lbs. occasionally with assistance.
• Frequent standing, walking, stooping, kneeling, and reaching.
• Vision requirements include close, distance, color, and peripheral vision, as well as depth perception.Truvian's Commitment to Equal Opportunity: Truvian is an equal-opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Our policy prohibits discrimination and harassment based on race, color, religion, gender, age, disability, veteran status, sexual orientation, or any other protected status.Apply today and join us on our journey to revolutionize healthcare diagnostics!
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Keywords: Sky Mavis, Highland , Senior Quality and Regulatory Affairs Manager, Executive , San Diego, California