Regulatory Affairs Senior Specialist - MedTech (Orthopedic)

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

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.