Regulatory Affairs Senior Specialist

Highridge Medical•Westminster, CO

1d•$85,000 - $110,000•Onsite

About The Position

Highridge Medical creates innovative spinal solutions and is seeking a purpose-driven Regulatory Affairs Senior Specialist to join their growing team. This role is focused on new product introduction and involves working closely with project teams to develop and execute regulatory strategies for submissions in the US and internationally. The position offers opportunities to engage with surgeons, attend surgical labs, and be immersed in the product development process. The ideal candidate will enjoy owning projects, collaborating with a development team, and possess submission experience. While medical device experience is preferred, strong writing skills and experience in an adjacent field are also valued.

Requirements

Must be authorized to work in the U.S. without requiring employer sponsorship, now or in the future.
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.
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.
MUST have submission writing experience.
Bachelor’s degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred.
A minimum of 5-7 years of experience in Regulatory Affairs, Engineering, Quality, or related field.
Combination of education and experience may be considered.

Nice To Haves

Understanding of medical devices.
Experience in an adjacent field with strong writing skills.
Knowledge of overall business environment, ideally within the orthopedic industry.
Minimum of 2 years of experience in orthopedic or medical device industry.

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.