Manager, Regulatory Affairs and Compliance (Medical Devices)

Location: Allen, Texas, United States; full-time, onsite role.

Company

Nordson Medical designs, develops, and manufactures complex medical devices and component technologies for life-saving applications.

What you will do

• Develop, implement, and maintain quality and regulatory affairs systems, policies, procedures, and document control processes.
• Lead regulatory strategies, submissions, registrations, certifications, export certificates, and Declarations of Conformity for U.S. and international markets.
• Manage regulatory affairs and document control personnel, including resource planning, training, performance feedback, and mentoring.
• Evaluate reportable events, prepare MDRs and vigilance reports, and manage product recalls, field communications, investigations, and corrective actions.
• Advise product development teams on regulatory requirements, review design history files, and authorize labeling, marketing materials, protocols, and reports.
• Support internal and external audits, third-party testing, regulatory authority interactions, and continuous improvement initiatives.

Requirements

• Bachelor of Science degree in a relevant discipline.
• At least 10 years of medical device Regulatory Affairs experience, including 7 years with Class II/III devices; candidates with 5+ years may be considered with an advanced relevant degree.
• At least 5 years of project management experience.
• Expertise in FDA QSR, ISO 13485, EU MDR, Health Canada, and other applicable U.S. and international regulations, including auditing experience.
• Experience preparing MDRs and vigilance reports, filing FDA submissions, obtaining CE marking, and interacting with the FDA and Notified Bodies.
• Strong technical writing, communication, prioritization, organizational, analytical, and problem-solving skills.

Nice to have

• Knowledge of Japanese, Australian, and Brazilian regulatory requirements.
• Knowledge of ISO 14971 and IEC 60601.
• Experience with UL certification and third-party testing.
• RAPS RAC (US) or ASQ Certified Quality Auditor certification.
• Mechanical aptitude and experience reviewing design documentation.

Culture & Benefits

• Collaborative and inclusive work environment.
• Supportive culture within a growing medical technology organization.
• Investment in employee skill development and career advancement.
• Opportunity to contribute to components used in life-saving medical devices.