Regulatory Affairs Specialist

Responsibilities

• Support the Quality Assurance Manager in maintaining, monitoring, and improving the Quality Management System (QMS) for medical device products.
• Lead or support activities to prepare the organization for MDSAP certification, including coordination of documentation, processes, and internal readiness assessments.
• Ensure compliance with applicable ISO standards, FDA Quality Management System Regulation (QMSR), and other relevant global regulatory requirements.
• Support and coordinate international regulatory registrations, including preparation, review, and maintenance of regulatory submissions for multiple markets.
• Partner with cross-functional teams to drive continuous improvement of quality system processes and procedures.
• Affiliate with FDA inspections and other regulatory authority inspections by preparing documentation, coordinating responses, and supporting on-site activities.
• Contribute to internal and external audits, including planning, execution, and follow-up on corrective and preventive actions (CAPA).
• Lead or support complaint handling activities, including investigation, documentation, trending, and implementation of corrective actions.
• Support post-market surveillance activities by collecting, analyzing, and reporting product performance and safety data.
• Participate in supplier quality management activities, including evaluation, qualification, and ongoing monitoring of suppliers.
• Engage in design controls and validation activities to ensure products meet regulatory and quality requirements throughout development and lifecycle.
• Promote a culture of continuous compliance and quality awareness across the organization.
• Use analytical and problem-solving skills to identify quality and regulatory issues, propose solutions, and support data-driven decision-making.
• Communicate effectively with internal stakeholders to provide regulatory and quality guidance and to ensure alignment with applicable requirements.

Requirements

• Bachelor's degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or a related field.
• At least 3 years of experience in medical device Quality Assurance and/or Regulatory Affairs (QA/RA).
• Hands-on experience with ISO standards applicable to medical devices and the FDA Quality Management System Regulation (QMSR).
• Practical experience with corrective and preventive actions (CAPA), complaint handling, supplier quality, design controls, and validation in a medical device environment.
• Demonstrated expertise in regulatory affairs for medical devices, including understanding of global regulatory frameworks.
• Excellent analytical and problem-solving skills with the ability to make sound decisions based on data and regulatory requirements.
• Educational certifications such as Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or Six Sigma Green Belt/Black Belt.
• Experience with MDSAP-related activities or requirements in a medical device setting.
• Experience with Health Canada regulatory requirements.
• Experience with ANVISA regulatory requirements.
• Experience with EU Medical Device Regulation (EU MDR).
• Experience working in a stable, established medical device organization.
• Demonstrated ability to support international regulatory registrations and maintain compliance across multiple regions.

Qualifications

• Experience with Health Canada regulatory requirements.
• Experience with ANVISA regulatory requirements.
• Experience with EU Medical Device Regulation (EU MDR).
• Experience working in a stable, established medical device organization.
• Demonstrated ability to support international regulatory registrations and maintain compliance across multiple regions.

Skills

• Strong analytical and problem-solving skills.
• Effective communication and interpersonal skills.
• Collaborative mindset with cross-functional teams.
• Data-driven decision-making abilities.
• Knowledge of regulatory frameworks and global standards.
• Experience with MDSAP-related activities or requirements.
• Experience with Health Canada, ANVISA, and EU Medical Device Regulation (EU MDR).

Benefits

• Medical, dental, and vision coverage.
• Critical illness, accident, and hospital insurance.
• Life insurance (voluntary life and AD&D for the employee and dependents).
• Short and long-term disability insurance.
• Health Spending Account (HSA).
• Transportation benefits.
• Employee Assistance Program.
• Time off/leave (PTO, vacation, or sick leave).
• Workplace type: Fully onsite in Lenexa, KS.