Regulatory Affairs Manager

Job Title

Regulatory Affairs Manager

Vista Apex Solutions

Racine, WI

Director of Engineering, Regulatory and Quality

Vista Apex Solutions is a purpose-driven, clinician-focused healthcare platform bringing together leading dental brands, including Vista Apex, Perio Protect, and Perio Sciences. Our mission is to develop meaningful products that enhance clinicians’ treatment options and improve patient outcomes. With a value-added approach across R&D, operations, and customer experience. We empower clinicians to deliver confident, consistent, and elevated care.

At our core, we operate through five foundational pillars— Product Development + Clinician Involvement, Treatment Refinement + Simplified Workflow, Expanding Innovations + Trusted Partnerships, Inspired Foresight and Quality Assured + Personal Connections —guiding our approach to innovation, collaboration, and long-term partnership.

The Regulatory Affairs Manager is responsible for leading the development, implementation, and maintenance of the company’s Quality Systems, ensuring that all policies, procedures, documentation, and controls meet established quality and compliance standards. This role ensures that cGMP documentation and records consistently align with internal requirements and global regulatory expectations.

The Regulatory Affairs Manager provides regulatory leadership and support across the organization, ensuring compliance with Quality System Regulation (21 CFR 820), the European Medical Device Regulation (MDR), UKCA requirements, and ISO 13485:2016. The position oversees activities related to certification and surveillance audits and plays a key role in ensuring ongoing regulatory readiness.

This role continuously monitors manufacturing, product development, and quality operations to confirm adherence to FDA requirements and applicable international regulations. As standards evolve, the Regulatory Affairs Manager proactively adjusts quality and regulatory processes to ensure continued compliance and operational excellence.

• Ensures company compliance with externally controlled documents, including regulations, standards, and guidance documents.
• Reviews and evaluates revised or amended regulatory standards and implements required actions to maintain ongoing compliance.
• Provides support to internal teams to ensure adherence to the Company’s Quality Management System (QMS).
• Manages post-market surveillance activities through cross-functional collaboration and preparation of required reports.
• Facilitates, executes, and supports the internal audit schedule and associated auditing activities.
• Ensures compliance with the Company’s Quality System requirements through effective training and consistent application of policies, procedures, and processes.
• Provides regulatory guidance to Operations, Marketing, Product Development, and other cross-functional stakeholders.
• Manages domestic and international product registrations; collaborates with in-country distributors and internal teams to coordinate required documentation and submissions.
• Serves as the Company’s Person Responsible for Regulatory Compliance (PRRC) in accordance with MDR 2017/745 requirements.

• Education
  • Bachelor’s degree in Regulatory Affairs, Quality Management, Engineering, Life Sciences, or a related field required.
  • Advanced degree (MS, MBA, or similar) preferred but not required.
  • Regulatory or quality-related certifications (e.g., RAC, ASQ, ISO Lead Auditor) are a plus.
• Experience
  • 5+ years of experience in Regulatory Affairs, Quality Assurance, or Quality Systems within the medical device or dental equipment manufacturing industry.
  • Demonstrated experience managing or supporting compliance with 21 CFR 820, EU MDR, UKCA, and ISO 13485:2016 standards.
  • Experience preparing for and supporting external certification, surveillance, and regulatory audits.
  • Hands‑on experience developing, implementing, and maintaining Quality Management Systems (QMS).
  • Proven track record ensuring conformance to FDA and international medical device regulations.
  • Experience monitoring manufacturing and development processes…