Global Medical Device Regulatory Strategist

CEDENT; Dallas (TX); Hybrid; USD 80,000 - 100,000; Full time

Job summary

CEDENT is looking for a Regulatory Affairs Consultant to join their team in Dallas, TX. The role involves developing regulatory strategies for medical devices, ensuring compliance with global standards, and preparing necessary submission documents. The ideal candidate will possess strong communication skills and have experience with FDA and international regulations.

The position requires a minimum of 3 years of experience in regulatory affairs within the medical device sector and a Bachelor’s degree in Life Sciences or Engineering. A proactive approach to problem-solving and the ability to collaborate with cross-functional teams are essential.

Qualifications

• Minimum of 3 years of experience in regulatory affairs, preferably in the medical device industry.
• Proven track record of successful regulatory submissions with FDA and CE.
• Excellent written and verbal communication skills.

Responsibilities

• Develop and implement regulatory strategies for medical devices.
• Prepare and review regulatory submission documents.
• Ensure compliance with global regulations.

Skills

Regulatory requirements knowledge

Communication skills

Problem-solving

Education

Bachelor’s degree in Life Sciences or Engineering

Tools

Regulatory software tools

Job description

CEDENT is looking for a Regulatory Affairs Consultant to join their team in Dallas, TX. The role involves developing regulatory strategies for medical devices, ensuring compliance with global standards, and preparing necessary submission documents. The ideal candidate will possess strong communication skills and have experience with FDA and international regulations.

The position requires a minimum of 3 years of experience in regulatory affairs within the medical device sector and a Bachelor’s degree in Life Sciences or Engineering. A proactive approach to problem-solving and the ability to collaborate with cross-functional teams are essential.