Medical Device Regulatory Strategist (Global Submissions)

Urgo Medical Canada; Fort Worth (TX); On-site; USD 75,000 - 90,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance (company-paid)

Disability Insurance

401(k) with company match

Paid time off

Paid family leave

Job summary

Urgo Medical is seeking a Regulatory Affairs Specialist to support regulatory strategies, submissions, labeling reviews, and compliance across global markets. The role focuses on 510(k) submissions, technical files, and coordinating regulatory timelines.

Located onsite in Fort Worth, Texas, the candidate should have 3–6 years of regulatory affairs experience in medical devices and strong knowledge of FDA regulations and ISO 13485. Travel is minimal.

Qualifications

• Bachelor’s degree in Life Sciences, Regulatory Affairs, or related field.
• 3–6 years of regulatory affairs experience in medical devices.
• Experience with regulatory submissions (510(k)).
• Working knowledge of FDA regulations (21 CFR Part 820) and ISO 13485.
• Familiarity with global regulatory requirements (MDR, Health Canada, LATAM).

Responsibilities

• Support regulatory strategies for new and existing products.
• Prepare, compile, and maintain regulatory submissions (510(k), technical documentation).
• Coordinate submission activities and timelines for approvals.
• Review product labeling, IFUs, and promotional content for compliance.

Skills

Regulatory affairs

Attention to detail

Cross-functional collaboration

Project management

Analytical thinking

Education

Bachelor’s Degree in Life Sciences or related

Tools

Regulatory submissions (510(k))

FDA regulations (21 CFR Part 820)

ISO 13485

MDSAP

Job description

Urgo Medical is seeking a Regulatory Affairs Specialist to support regulatory strategies, submissions, labeling reviews, and compliance across global markets. The role focuses on 510(k) submissions, technical files, and coordinating regulatory timelines.

Located onsite in Fort Worth, Texas, the candidate should have 3–6 years of regulatory affairs experience in medical devices and strong knowledge of FDA regulations and ISO 13485. Travel is minimal.