Global Regulatory Affairs Lead for MedTech Submissions

BD; Salt Lake City (UT); Hybrid; USD 110,000 - 140,000; Full time

Job summary

BD in Salt Lake City, UT seeks a Senior Regulatory Affairs Specialist to lead regulatory submissions and ensure compliance across global markets. You will partner with R&D, Quality, Manufacturing, and Marketing to craft robust regulatory strategies for medical devices.

The role involves preparing 510(k) submissions, CE technical files, and change notifications while coordinating with health authorities and Notified Bodies. Onsite hybrid work 4 days a week in Salt Lake City.

Qualifications

• Bachelor's degree in engineering, bioengineering, biology, chemistry, or health science.
• At least 3 years of regulatory experience in the medical device industry.
• Familiarity with FDA, EU MDR 2017/745, ISO 13485.

Responsibilities

• Support FDA 510(k) submissions and other FDA documentation formats.
• Prepare technical files for CE marking with input from R&D, Quality, Manufacturing.
• Submit notifications for significant changes to registered products to geographies (EU Notified Bodies, etc.).
• Interact with health agencies reviewers during submissions.
• Review and authorize labeling for regulatory compliance.
• Assist in clinical evaluation reports for regulatory submissions.

Skills

Regulatory strategy

Cross-functional coordination

Documentation management

Regulatory submissions

Regulatory communications

Education

Bachelor's degree in engineering/biological/health sciences

Job description

BD in Salt Lake City, UT seeks a Senior Regulatory Affairs Specialist to lead regulatory submissions and ensure compliance across global markets. You will partner with R&D, Quality, Manufacturing, and Marketing to craft robust regulatory strategies for medical devices.

The role involves preparing 510(k) submissions, CE technical files, and change notifications while coordinating with health authorities and Notified Bodies. Onsite hybrid work 4 days a week in Salt Lake City.