Regulatory Strategy Lead – Medical Devices

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

Benefits offered by this job

Bonus DOE

Job summary

HIGHRIDGE Inc. is seeking a Regulatory Affairs professional to lead strategies for new product introductions and global registrations. You will collaborate with cross-functional teams, review labeling, and drive regulatory submissions for the US and international markets.

The role requires strong writing skills, attention to detail, and at least 5–7 years in Regulatory Affairs or related fields within the medical device sector. Travel up to 15% is expected.

Qualifications

• Must have submission writing experience.
• Bachelor’s degree in life sciences, technical/engineering or related field; non-US equivalent acceptable.
• 5–7 years of experience in Regulatory Affairs, Engineering, or related field.
• 2+ years in orthopedic or medical device industry preferred.

Responsibilities

• Own regulatory activities for a brand from new product introduction to changes and international registration.
• Prepare and submit regulatory documentation for domestic and international markets (PMA, HDE, 510(k), letters to file, Tech Docs).
• Provide regulatory direction to development project teams as a core team member.
• Develop regulatory strategy for new products and assess risk with viable solutions.
• Review labeling and product changes for regulatory impact and compliance.
• Contribute to development and maintenance of IFU and Surgical Technique Guides.
• Review promotional materials for compliance and communicate with regulatory agencies.

Skills

Regulatory writing

Regulatory knowledge

Attention to detail

Communication

Multi-tasking

Team collaboration

Industry knowledge (orthopedic)

Education

Bachelor's degree in life sciences or engineering

Job description

HIGHRIDGE Inc. is seeking a Regulatory Affairs professional to lead strategies for new product introductions and global registrations. You will collaborate with cross-functional teams, review labeling, and drive regulatory submissions for the US and international markets.

The role requires strong writing skills, attention to detail, and at least 5–7 years in Regulatory Affairs or related fields within the medical device sector. Travel up to 15% is expected.