Vice President Regulatory Affairs Quality Assurance

Vice President Regulatory Affairs Quality Assurance at Maclivaro Limited Vice President Regulatory Affairs Quality Assurance at Maclivaro Limited in West Valley City, Utah Posted in 1 day ago.

Type:

full-time

Job Description:

Vice President, Regulatory Affairs & Quality Assurance United States - Salt Lake City Medical Device & Biomaterials Sector $180,000 - $225,000 Base + Bonus + RSUs An innovative and rapidly growing medical device and biomaterials company is seeking a Vice President of Regulatory Affairs & Quality Assurance to lead global regulatory strategy and quality operations across next-generation implantable technologies and advanced biomaterial platforms. This is a key executive leadership role within a highly specialised organisation focused on developing and commercialising cutting-edge implantable medical technologies, including additive manufacturing, patient-specific solutions, and advanced biomaterial applications. The successful candidate will play a critical role in driving regulatory approvals, strengthening quality systems, supporting commercial scale-up, and enabling future growth through strategic partnerships and licensing initiatives. The Opportunity You will lead the global Regulatory Affairs and Quality Assurance function, overseeing regulatory submissions, compliance strategy, quality systems, manufacturing quality, and post-market activities across a portfolio of innovative medical technologies. This role requires a strategic yet hands-on leader who can operate effectively within a fast-paced, growth-stage environment while balancing innovation with regulatory and quality rigor. Key Responsibilities Regulatory Affairs Leadership Develop and execute US and international regulatory strategies for: Implantable medical devices Additively manufactured and patient-specific technologies Biomaterial-based platforms and applications Wound management and soft tissue technologies Lead and manage FDA submissions including: 510(k) De Novo IDE PMA Q-Submissions Serve as the primary regulatory interface with FDA and international regulatory authorities Assess regulatory risks, timelines, and market access strategies for new products and design changes Quality Systems & Compliance Own and continuously improve the Quality Management System (QMS) Ensure compliance with: 21 CFR Part 820 ISO 13485 ISO 14971 Applicable ASTM and additive manufacturing standards

Oversee:

Design controls Process controls Supplier quality CAPA Change control Complaint handling Internal and external audits Support scalable manufacturing readiness and commercial growth Product Launch & Lifecycle Management Provide regulatory and quality leadership for new product launches and lifecycle management activities Support manufacturing scale-up, process validation, and risk mitigation initiatives Oversee post-market surveillance and vigilance activities Collaborate cross-functionally with R D, Manufacturing, Clinical, and Commercial teams Strategic & Cross-Functional Leadership Act as a key advisor to executive leadership on regulatory and quality matters Manage relationships with notified bodies, testing laboratories, consultants, and strategic partners Support licensing, co-development, and commercial partnership activities Contribute to investor and board-level regulatory communications Requirements Required Experience Bachelor's degree in Engineering, Life Sciences, or related discipline (Master's preferred) 10+ years of progressive Regulatory Affairs and Quality experience within medical devices, orthopaedics, biomaterials, or related sectors Strong FDA submission experience including: 510(k) De Novo IDE PMA Deep understanding of:

FDA QSR ISO 13485 ISO 14971

Medical device quality systems Experience supporting manufacturing quality, supplier quality, and regulatory audits Highly Preferred Additive manufacturing / 3D-printed medical devices Patient-specific or custom implant technologies Biomaterials or materials-science-driven products Experience with antimicrobial or antipathogenic technologies Direct FDA interaction experience including Q-Subs and inspections Lean Six Sigma certification and process improvement expertise What's on Offer $180,000 - $225,000 base salary Bonus opportunity RSUs / equity participation Opportunity to shape the regulatory and quality strategy of a highly innovative medtech platform business High-impact executive leadership role within a growth-stage organisation