Senior Regulatory Affairs Lead — Spine Devices

HIGHRIDGE Inc.; Westminster (CO); On-site; USD 85,000 - 110,000; Full time

Job summary

Highridge Medical is seeking a Regulatory Affairs professional to lead regulatory activities for the spine portfolio, guiding submissions and international registrations. The role requires strong writing and collaboration with project teams to ensure compliance across markets.

The ideal candidate has 5–7 years in regulatory affairs or related fields, a Bachelor's degree, and submission writing experience. Travel up to 15% with a competitive salary and DOE is offered.

Qualifications

• Must have submission writing experience.
• Bachelor's degree (or non-US equivalent) in life sciences, engineering, or related field preferred.
• Minimum of 5–7 years in Regulatory Affairs, Engineering, Quality, or related field.

Responsibilities

• Own regulatory activities for brand from new product introduction to changes and international registration.
• Prepare and submit regulatory documentation for domestic and international markets (PMA, HDE, 510ks, etc.).
• Provide regulatory direction for development project teams as a core member.
• Develop regulatory strategies for new products and evaluate risk with actionable solutions.
• Review labeling for compliance with global regulations and assess changes on regulatory status.
• Contribute to development and maintenance of Instructions for Use and Surgical Technique Guides.

Skills

Strong writing

Regulatory affairs

FDA/EU regulations

Communication skills

Multi-tasking

Team collaboration

Education

Bachelor's degree

Job description

Highridge Medical is seeking a Regulatory Affairs professional to lead regulatory activities for the spine portfolio, guiding submissions and international registrations. The role requires strong writing and collaboration with project teams to ensure compliance across markets.

The ideal candidate has 5–7 years in regulatory affairs or related fields, a Bachelor's degree, and submission writing experience. Travel up to 15% with a competitive salary and DOE is offered.