Senior Regulatory Affairs Specialist

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.

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

Expected Areas of Competence (i.e., knowledge, skills, and abilities)

• 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

• 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 years of experience in Regulatory Affairs, Engineering, Quality, or related field.
• Combination of education and experience may be considered.

Travel Requirements

Up to 15%