Regulatory Affairs Specialist

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

Responsibilities

• This role is responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product development process and sustaining engineering projects, ensuring compliance with FDA and EU regulations, ISO standards, and other regulatory agencies
• Coordinate, compile, and submit US and EU regulatory filings for new and modified products, including PMAs, PMA supplements, pre-submissions, 510(k)s, annual reports, and 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, providing regulatory feedback and guidance throughout the product and manufacturing process development cycle, commercialization, and coordinating team inputs for submissions
• Act as a company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review
• Review and approve design and manufacturing changes for existing products, ensuring compliance with applicable regulations
• Interact with regulatory agencies as part of submission review and on-site audit support
• Review device labeling for compliance with global regulations; analyze and recommend appropriate changes
• Support and maintain Quality initiatives in accordance with BSC Quality Policy
• Participate in development and implementation of departmental policies and procedures
• Foster a work environment of continuous improvement that supports BSC's Quality Policy, Quality System and the appropriate regulations for their area of responsibility

Responsibilities

• This role is responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product development process and sustaining engineering projects, ensuring compliance with FDA and EU regulations, ISO standards, and other regulatory agencies
• Coordinate, compile, and submit US and EU regulatory filings for new and modified products, including PMAs, PMA supplements, pre-submissions, 510(k)s, annual reports, and 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, providing regulatory feedback and guidance throughout the product and manufacturing process development cycle, commercialization, and coordinating team inputs for submissions
• Act as a company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review
• Review and approve design and manufacturing changes for existing products, ensuring compliance with applicable regulations
• Interact with regulatory agencies as part of submission review and on-site audit support
• Review device labeling for compliance with global regulations; analyze and recommend appropriate changes
• Support and maintain Quality initiatives in accordance with BSC Quality Policy
• Participate in development and implementation of departmental policies and procedures
• Foster a work environment of continuous improvement that supports BSC's Quality Policy, Quality System and the appropriate regulations for their area of responsibility

Requirements

• A minimum of a bachelor's degree, preferably in a scientific or technical discipline.
• A minimum of 2-year work experience in Regulatory Affairs or 3 years' work experience in a related discipline (e.g., R&D, Quality, Clinical, Medical Affairs, Biocompatibility) in the medical device industry.
• Introductory knowledge of FDA, EU and/or international regulations.
• Proficiency with Microsoft Office applications (Word, Excel, PowerPoint, Teams, SharePoint, MS Forms).