Sr. Reg Affairs Specialist

HighRidge Medical LLC•Westminster, CO

About The Position

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.

Requirements

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
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

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
May provide training and/or guidance to entry-level associates, analysts, interns, and specialists