Regulatory Affairs Senior Specialist

Regulatory Jobs; Westminster (CO); On-site; USD 85,000 - 110,000; Full time

Job summary

Highridge Medical is seeking a Regulatory Affairs Senior Specialist in Westminster, CO. You will lead regulatory activities for new products and changes, manage domestic and international submissions, and guide project teams through regulatory strategy from inception to approval.

Ideal candidates have strong technical writing skills, 5-7 years in Regulatory Affairs or related fields, and a background in orthopedic/medical devices.

Qualifications

• Must have submission writing experience.
• Bachelor’s degree (or non-US equivalent) required; life sciences, engineering or related field preferred.
• Minimum of 5-7 years of experience in Regulatory Affairs, Engineering, Quality, or related field.
• (Preferred) Minimum of 2 years of experience in orthopedic or medical device industry.
• Combination of education and experience may be considered.

Responsibilities

• Own regulatory activities for a brand from new product introduction to revisions and international registration support.
• Prepare and submit regulatory documentation for domestic and international markets, ensuring compliance with PMA, HDE, 510(k)s, 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 risks and offering solutions.
• Review labeling for compliance with global regulations.
• Review product changes for impact on regulatory status.
• Contribute to creation and maintenance of Instructions for Use and Surgical Technique Guides.
• Review and evaluate promotion and advertising material for regulatory compliance.
• Communicate with regulatory and governmental agencies.
• May provide training to entry-level associates, analysts, interns, and specialists.

Skills

Regulatory writing

Communication

Detail oriented

Multitasking

Regulatory affairs

Education

Bachelor's degree

5-7 years RA experience

Medical device experience

Tools

Regulatory submission software

Job description

Regulatory Affairs Senior Specialist

Must be authorized to work in the U.S. without requiring employer sponsorship, now or in the future.

Highridge Medical creates the world’s most innovative spinal solutions across the spectrum from Motion Preservation to MIS to Bone Healing to Core Spine. Working at HIGHRIDGE is not just work. Life at Highridge Medical is purpose-driven. Every day, you have the privilege of using your talents to demonstrate Confidence in your work and restore Confidence for our patients. Confidence that moves.

Here at Highridge Medical, it is GO TIME, and we want people to join the growing Highridge team who have the passion to climb the next summit with us to provide patients and surgeons with the products they need. We are interested in finding someone who enjoys owning projects, interacting with a wider development team, and has submission experience. We prefer an understanding of medical devices, but if you have strong writing skills and experience in an adjacent field, drop us your resume.

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

This description is not intended to be an exhaustive list of all duties and responsibilities. Duties and responsibilities may change based on business needs. The Company will evaluate the essential functions of the position in accordance with applicable law.

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

• 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%

Salary Range $85,000.00- $110,000.00 + Bonus DOE