Senior Regulatory Strategy Lead - Medical Devices

HIGHRIDGE Inc.; Olive Branch (MS); On-site; USD 85,000 - 100,000; Full time

Job summary

Highridge Medical in Olive Branch, MS is seeking a Regulatory Affairs Senior Specialist authorized to work in the U.S. You will own regulatory activities for the brand, manage product submissions and provide strategic regulatory direction across development teams.

You will interact with surgeons and labs, review labeling and advertising for compliance, and train entry-level staff while driving regulatory strategies to completion with FDA and international bodies.

Qualifications

• Bachelor’s degree in life sciences, engineering, or related field.
• Minimum 5–7 years in Regulatory Affairs or related area.
• Experience with orthopedic/medical device submissions preferred.

Responsibilities

• Own regulatory activities for brand from NPI to changes and international registration.
• Prepare and submit domestic and international regulatory documentation (PMA, 510(k), EU submissions).
• Provide regulatory direction for development teams and strategy for new products.
• Review labeling and advertising for regulatory compliance; train junior staff.

Skills

Strong writing

Regulatory knowledge

Attention to detail

Multi-tasking

Team collaboration

FDA EU knowledge

Education

Bachelor's degree in life sciences/engineering

Job description

Highridge Medical in Olive Branch, MS is seeking a Regulatory Affairs Senior Specialist authorized to work in the U.S. You will own regulatory activities for the brand, manage product submissions and provide strategic regulatory direction across development teams.

You will interact with surgeons and labs, review labeling and advertising for compliance, and train entry-level staff while driving regulatory strategies to completion with FDA and international bodies.