Regulatory Affairs Lead - Medical Devices Submissions

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

Job summary

Highridge Medical seeks a Regulatory Affairs Senior Specialist to lead regulatory activities for key brands, guiding strategies from product concept to international submissions. You will collaborate with development teams to ensure compliant documentation and registration across markets.

The ideal candidate has strong writing skills, a track record in submissions, and at least 5–7 years in regulatory affairs or related fields within the medical device sector.

Qualifications

• MUST have submission writing experience.
• Minimum 5-7 years in Regulatory Affairs, Engineering, Quality, or related field.
• Experience in orthopedic or medical device industry preferred.

Responsibilities

• Own regulatory activities for the brand, from new product introduction to product changes and international registration.
• Prepare and submit regulatory documentation for domestic and international markets, ensuring compliance.
• Provide regulatory direction for development project teams as a core team member.
• Develop regulatory strategy for new products, evaluating risk and offering solutions.
• Review labeling for compliance with applicable global regulations and communicate with agencies.

Skills

Strong writing

Attention to detail

Regulatory strategy

Project ownership

Education

Bachelor’s degree in life sciences

Job description

Highridge Medical seeks a Regulatory Affairs Senior Specialist to lead regulatory activities for key brands, guiding strategies from product concept to international submissions. You will collaborate with development teams to ensure compliant documentation and registration across markets.

The ideal candidate has strong writing skills, a track record in submissions, and at least 5–7 years in regulatory affairs or related fields within the medical device sector.