Senior Regulatory Affairs Specialist - Spine Medical Device

Highridge Medical LLC; Westminster (CO); Presencial; USD 85.000 - 110.000; Jornada completa

Descripción de la vacante

Highridge Medical LLC is seeking a Regulatory Affairs Senior Specialist who will own regulatory activities for brand development, from new product introductions through changes and international registrations. You will prepare submissions and guide development teams in regulatory strategy to ensure compliant products for the U.S.

and global markets. The role requires submission writing experience and a strong background in FDA/EU regulations, with 5–7 years in Regulatory Affairs or related

Formación

• MUST have submission writing experience
• Bachelor’s degree (or non-US equivalent) in life sciences, technical/engineering or related field preferred
• Minimum of 2 years of experience in orthopedic or medical device industry
• A minimum of 5-7 years of experience in Regulatory Affairs, Engineering, Quality, or related field

Responsabilidades

• Own regulatory activities for brand, from new product introduction to product changes and international registration support
• Prepare and submit regulatory documentation for domestic and international markets
• Provide regulatory direction for development project teams as a core team member
• Develop regulatory strategy for new products, evaluate risk, and propose solutions
• Review labeling for compliance with global regulations
• Review product changes for regulatory impact
• Contribute to Instructions for Use and Surgical Technique Guides
• Review promotional material for regulatory compliance
• Communicate with regulatory and governmental agencies
• May provide training to entry-level staff and specialists
• Support additional regulatory compliance items as required by regulations and team needs

Conocimientos

Regulatory knowledge

Regulatory writing

Technical writing

Communication skills

Attention to detail

Multi-tasking

Stakeholder collaboration

FDA/EU regulations

Educación

Bachelor's degree in life sciences/engineering

Descripción del empleo

Highridge Medical LLC is seeking a Regulatory Affairs Senior Specialist who will own regulatory activities for brand development, from new product introductions through changes and international registrations. You will prepare submissions and guide development teams in regulatory strategy to ensure compliant products for the U.S.

and global markets. The role requires submission writing experience and a strong background in FDA/EU regulations, with 5–7 years in Regulatory Affairs or related