Regulatory Affairs Manager

VistaApex Solutions • Racine, WI

12d

About The Position

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.

Requirements

• Bachelor’s degree in Regulatory Affairs, Quality Management, Engineering, Life Sciences, or a related field required.
• 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 to maintain regulatory compliance as standards evolve.
• Strong 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.

Nice To Haves

• 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.

Responsibilities

• 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.

Benefits

• Comprehensive Health Coverage : Medical, dental, and vision insurance for you and your dependents.
• Time Off : Generous PTO policy and paid holidays
• Retirement 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level