Global Regulatory Strategy Director

Argon Medical Devices, Inc.; Plano (TX); On-site; USD 130,000 - 160,000; Full time

Job summary

Argon Medical Devices, Inc. in Plano, Texas, is seeking a Director of Regulatory Affairs to lead strategic initiatives ensuring regulatory compliance while driving business growth. This key role involves developing regulatory strategies and mentoring teams, all while maintaining compliance with global health authorities like FDA and EUMDR.

The ideal candidate has over 8-12 years of experience in a medical device environment and a BS/MS in a related field. Strong leadership and analytical skills are essential for success in this role.

Qualifications

• Progressive experience at a global manufacturer of medical devices or at a regulatory agency.
• Knowledge of FDA and global health authorities like EUMDR, PMDA, etc.
• Skills in regulatory compliance and quality management systems.

Responsibilities

• Oversee regulatory requirements and product submission strategies.
• Work with teams to shape regulatory strategy for product development.
• Mentor regulatory affairs and cross-functional teams.

Skills

BS/MS in (Biomedical) Engineering, Science or related field

8-12 years’ experience at a global manufacturer of medical devices

Comprehensive knowledge of global regulatory requirements

Expert knowledge of FDA regulations and ISO standards

Strong analytical and organizational skills

Excellent leadership and communication skills

Education

BS/MS in (Biomedical) Engineering, Science, or a related field

Job description

Argon Medical Devices, Inc. in Plano, Texas, is seeking a Director of Regulatory Affairs to lead strategic initiatives ensuring regulatory compliance while driving business growth. This key role involves developing regulatory strategies and mentoring teams, all while maintaining compliance with global health authorities like FDA and EUMDR.

The ideal candidate has over 8-12 years of experience in a medical device environment and a BS/MS in a related field. Strong leadership and analytical skills are essential for success in this role.