Summary

This role leads global regulatory compliance efforts for a medical device manufacturing organization. You’ll manage product registrations and licensing across U.S. and international markets, oversee quality system adherence, and act as the key liaison during regulatory audits and inspections. The position requires strong leadership and deep knowledge of global regulatory frameworks, device compliance, and quality systems.

Job Duties

• Drive end-to-end regulatory submissions and product registration activities for new and existing products in multiple global regions.

• Maintain and continually improve the organization’s compliance structure to align with U.S. and international medical device regulations.

• Act as the primary point of contact during regulatory inspections, audits, and notified body interactions.

• Review materials, product documentation, technical files, and labeling for regulatory accuracy and compliance.

• Track evolving global regulatory requirements and advise leadership on necessary updates and impacts.

• Oversee internal quality system practices including audits, complaint reporting, CAPAs, adverse event reporting, and recall coordination.

• Lead, coach, and develop the Regulatory Affairs team; ensure consistency in standards and documentation practices.

• Provide cross-functional guidance on regulatory pathways, compliance expectations, and industry best practices.

• Support customer, OEM, and third-party audits as needed.

Qualifications

• Bachelor’s degree in a scientific, engineering, regulatory, or related discipline (or equivalent hands-on experience).

• 5+ years in Regulatory Affairs, Quality, or Compliance within medical devices or a closely related regulated environment.

• Strong working knowledge of U.S. FDA Quality System Regulations, ISO 13485, ISO 14971, and global medical device compliance standards.

• Familiarity with biocompatibility evaluations, sterilization methods, packaging validations, and risk management processes.

• Demonstrated expertise in navigating and implementing EUMDR requirements.

• Proven ability to lead teams, communicate clearly, and influence at multiple levels of an organization.

• Proficiency in standard office software; ability to quickly learn new regulatory or quality platforms.