Regulatory Affairs Manager

• 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 to maintain regulatory compliance as standards evolve.
• Skills and Competencies
  • 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.

• 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 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.

• 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.

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.