MedTech Regulatory Affairs Strategist

Katalyst CRO; Richmond (IL); On-site; USD 90,000 - 130,000; Full time

Job summary

Katalyst CRO in the United States seeks a Regulatory Affairs professional to support submissions and ongoing compliance for medical device development and sustaining projects. You will coordinate US/EU filings, develop regulatory strategies, and guide teams through submissions and changes.

Collaborate with reviewers, manage labeling reviews, and support quality initiatives under the BSC policy framework. A bachelor’s degree and relevant regulatory experience are required.

Qualifications

• Bachelor's degree in a scientific or technical field.
• 2 years in Regulatory Affairs or 3 years in related medical device disciplines.
• Introductory knowledge of FDA, EU and international regulations.
• Proficiency with Microsoft Office applications (Word, Excel, PowerPoint).

Responsibilities

• Regulatory affairs support of submissions and ongoing regulatory compliance for product development and sustaining engineering projects.
• Coordinate, compile, and submit US and EU regulatory filings for new and modified products (PMAs, 510(k)s, MDR CE mark submissions).
• Develop and implement regulatory strategies for new and modified products.
• Act as a core team member on sustaining and new product development projects; provide regulatory feedback throughout the process.

Skills

Regulatory affairs

Regulatory strategy

Project coordination

Education

Bachelor's degree in a scientific or technical field

Tools

Microsoft Word

Excel

PowerPoint

Teams

SharePoint

Job description

Katalyst CRO in the United States seeks a Regulatory Affairs professional to support submissions and ongoing compliance for medical device development and sustaining projects. You will coordinate US/EU filings, develop regulatory strategies, and guide teams through submissions and changes.

Collaborate with reviewers, manage labeling reviews, and support quality initiatives under the BSC policy framework. A bachelor’s degree and relevant regulatory experience are required.