Senior Regulatory Affairs Specialist
HighRidge Medical LLC
Summary
Highridge Medical creates the world's most innovative spinal solutions across the spectrum from Motion Preservation to MIS to Bone Healing to Core Spine. This person will be joining a small, but mighty team and will have the opportunity to work on a variety of projects, focused on new product introduction, for the world's largest privately held spine company. As an RA team member, you will work closely with project teams to develop regulatory strategies and drive those strategies to completion through submission in the US and internationally. You will have the opportunity to attend surgical labs, meet surgeons, and immerse yourself in the development process.
Job description
Principal Duties and Responsibilities
- Become a brand champion, owning regulatory activities for that brand, from new product introduction to product changes and revisions, and international registration support.
- Prepare and submit regulatory documentation for domestic and international markets, ensuring compliance with applicable regulations (i.e. PMA, HDE, 510ks, letters to file, and Tech Docs)
- Provide regulatory direction for development project teams as a core team member
- Develop regulatory strategy for new products, evaluating risk of proposed strategies and offering solutions
- Review proposed labeling for compliance with applicable global regulations
- Review proposed product changes for impact on regulatory status of the products
- Contribute to the development and maintenance of Instructions for Use and Surgical Technique Guides
- Review and evaluate promotion and advertising material for compliance with applicable regulations
- Communicate with regulatory and governmental agencies
- May provide training and/or guidance to entry-level associates, analysts, interns, and specialists
- Support additional regulatory compliance items as required by regulations and as needed by the RA team
Expected Areas of Competence
- Strong writing, communication, and interpersonal skills
- Strong attention to detail
- Able to multi-task and balance competing priorities, and willingness to work with changing priorities
- Self-motivated professional who can manage priorities and work independently in a fast-paced environment
- Knowledge of overall business environment, ideally within the orthopedic industry
- Eager to build relationships between Regulatory Affairs and other teams within the organization
- Ability to communicate effectively at all levels
- Advanced knowledge of FDA, EU, and other regulatory body regulations
Education/Experience Requirements
- MUST have submission writing experience
- Bachelor's degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred.
- (Preferred) Minimum of 2 years of experience in orthopedic or medical device industry.
- (Required) A minimum of 5-7 years of experience in Regulatory Affairs, Engineering, Quality, or related field.
- Combination of education and experience may be considered.
Travel Requirement: Up to 15%
Requirements
- Must be authorized to work in the U.S. without requiring employer sponsorship, now or in the future
- MUST have submission writing experience
- Bachelor's degree (or non-US equivalent) required
- Minimum of 5-7 years of experience in Regulatory Affairs, Engineering, Quality, or related field
- Minimum of 2 years of experience in orthopedic or medical device industry (preferred)
- Strong writing, communication, and interpersonal skills
- Strong attention to detail
- Able to multi-task and balance competing priorities
- Self-motivated professional who can manage priorities and work independently
- Knowledge of overall business environment, ideally within the orthopedic industry
- Ability to communicate effectively at all levels
- Advanced knowledge of FDA, EU, and other regulatory body regulations
Benefits
- Bonus DOE
- Up to 15% travel
Company overview
HighRidge Medical LLC is a global medical device company specializing in innovative spinal solutions, established in 2024 and headquartered in Westminster, Colorado. As one of the world's largest privately held spine companies, HighRidge focuses on partnering with surgeons to drive innovation across the spectrum of spinal care. The company maintains a strong portfolio supported by extensive clinical evidence, offering solutions for complex spine procedures, motion preservation technologies, minimally invasive surgery (MIS), bone healing, and core spine applications. HighRidge Medical operates with a surgeon-focused approach, developing products that enhance surgical accuracy, streamline procedural workflows, and improve clinical outcomes. The company has demonstrated significant growth through strategic acquisitions, including assets from Accelus, and maintains distribution partnerships with companies like Osteotec. With approximately 1,001-5,000 employees globally, HighRidge serves patients worldwide while maintaining a commitment to value-based care and technological advancement in spinal surgery.