Regulatory Affairs Manager

Job Title: Regulatory Affairs ManagerCompany: VistaApex SolutionsLocation: Racine, WIReports to: Director of Engineering, Regulatory and QualityAbout VistaApex SolutionsVistaApex Solutions is a purpose-driven, clinician-focused healthcare platform bringing together leading dental brands, including Vista Apex, PerioProtect, and PerioSciences. 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.Position OverviewThe 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.Key FunctionsEnsures 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.QualificationsEducationBachelor’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.Experience5 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 to maintain regulatory compliance as standards evolve.Skills and CompetenciesStrong understanding of Quality Systems, cGMP documentation, and regulatory requirements for medical devices.Ability to interpret and apply domestic and international regulatory standards, including FDA, EU MDR, UKCA, and ISO 13485.Skilled in developing and optimizing policies, procedures, and controlled documentation.Excellent analytical and problem-solving abilities with strong attention to detail.Effective communication skills for cross-functional collaboration with manufacturing, quality, R&D, and leadership teams.Strong organizational skills with the ability to manage multiple regulatory projects and timelines.Ability to lead teams through audits and ensure continuous regulatory readiness.Proactive approach to identifying regulatory changes and implementing necessary updates to maintain compliance.Physical DemandsThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.Frequently required to sit for extended periods while performing desk-based regulatory and documentation tasks.Regular use of hands for typing, writing, document management, and computer work.Occasional standing, walking, or reaching when accessing files, attending meetings, or visiting production areas.Ability to lift up to 20 lbs occasionally (e.g., document binders, audit materials, product samples).Visual acuity required for reviewing technical documents, regulatory submissions, product labeling, and electronic records.Ability to remain focused and detail-oriented for long periods when reviewing regulatory documentation or quality records.May require wearing appropriate PPE (e.g., safety glasses, protective footwear) when entering manufacturing spaces.Work EnvironmentThe work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.Work is performed primarily in an office environment within a manufacturing/production facility.Regular interaction with cross-functional departments such as Quality, Operations, Engineering, and Product Development.Occasional work performed in manufacturing areas, which may involve exposure to moderate noise, moving equipment, and standard industrial conditions.Requires use of standard office equipment including computers, phones, printers, and filing systems.May involve occasional travel to suppliers, regulatory agencies, notified bodies, or external audit locations.Must comply with all company safety policies and applicable regulatory requirements.BenefitsWe believe in supporting our employees both inside and outside of work. Here’s what you can expect when you join our team:Comprehensive Health Coverage: Medical, dental, and vision insurance for you and your dependents.Time Off: Generous PTO policy and paid holidaysRetirement Plans: 401(k) with company matching to help you plan for the future.Wellness Support: Mental health resources and wellness programs.Team Connection: Regular team events, retreats, and gatherings to build community.Location Requirement:Only candidates who reside in Racine, WI or the surrounding areas will be considered for this position. Applications from individuals outside the local region will not be reviewed.Pre-Employment Screening:All offers of employment are contingent upon successful completion of pre-employment screening, which may include background checks, employment verification, and other job-related assessments as permitted by law. Powered by JazzHRvP6uwzTuTo

Salary : $90,000