BioLab Holdings · 10 hours ago
Regulatory Affairs Manager
Mesa, AZ
Full-time
Onsite
Senior Level
5+ years expBioLab Holdings is a regenerative health company focused on providing innovative solutions that encourage the body to heal naturally. We are seeking an accomplished Regulatory Affairs Manager to architect and drive regulatory strategy for our complex products, ensuring timely market access and serving as a strategic partner to R&D and Executive Leadership.
BiotechnologyMedical
Hiring Manager
Hannah Levos
Responsibilities
Develop and execute global regulatory strategies for Class II and potentially combination products
Serve as the primary regulatory authority on product development teams, providing strategic input from concept through commercialization and post-market
Spearhead the preparation, authoring, and review of sophisticated regulatory submissions, demonstrating a proven track record with FDA Pre-Submissions, 510(k), De Novo, and IDE, Knowledge of BLA submissions for combination products, and Knowledge of EU MDR Technical Documentation and interactions with Notified Bodies
Act as the primary company representative in all interactions with the FDA and other global health authorities
Lead meeting strategy, prepare briefing packages, and negotiate submission content and data requirements
Provide deep regulatory oversight and guidance to the Clinical Affairs team
Review and approve clinical study protocols, reports, and statistical analysis plans to ensure global regulatory compliance and acceptance
Influence and guide R&D, Quality, Clinical, and Marketing leadership on regulatory requirements, risk management, and product development strategies
Mentor regulatory & quality staff and elevate the regulatory IQ across the organization
Maintain expert knowledge of evolving US and international regulations, standards, and guidance documents
Oversee regulatory aspects of post-market surveillance and product lifecycle management
Qualification
Required
Bachelor's degree in Engineering, Life Sciences, or a related technical field; advanced degree (MS, PhD, RAC) strongly desired
Minimum of 5-7+ years of progressive Regulatory Affairs experience within the medical device industry, with a focus on Class II devices
Demonstrated expert-level mastery in the preparation and successful clearance/approval of FDA 510(k) and at least one of the following: De Novo, IDE, and or BLA
Proven experience as the primary lead in formal FDA interactions (e.g., Pre-Sub, Panel Meetings)
Extensive background collaborating with Clinical Affairs on the development of clinical study protocols and management of IRB/IEC submissions
Superior written and verbal communication skills, with a demonstrated ability to articulate complex regulatory strategies to executive leadership and influence decision-making
Preferred
Direct experience with diverse device technologies such as optical/imaging systems or energy-based applications
Significant experience with Class II devices, combination products and an understanding of the nuances of BLA submissions are a plus
Proven success in preparing EU MDR Technical Documentation and interfacing with Notified Bodies
Experience building or mentoring regulatory teams or group
Benefits
Health, Dental, and Vision Insurance
Retirement Plans
Tuition Reimbursement
Generous Paid Time Off
Employee Assistance Program
No premium payments
Company
BioLab Holdings
BioLab Holdings, Inc. is a Phoenix-based medical manufacturer specializing in wound care solutions
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Bob Maguire
Founder, President & CEO
Scott Swonger
CFO
Recent News
2026-02-04
2026-01-09
2025-12-04
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