Regulatory Affairs Associate — Class III PMA Expert

Katalyst CRO; North Chicago (IL); On-site; USD 120,000 - 160,000; Full time

Job summary

Katalyst CRO in North Chicago seeks an experienced Regulatory Affairs Specialist contractor to oversee government filings for complex Class III implantable devices. You will lead PMA-related submissions and ensure CFR compliance across programs, collaborating with engineering, QA, and manufacturing teams.

The role requires 3–5 years of direct regulatory experience, strong document authoring, and a proven track record in PMA approvals.

Qualifications

• Bachelor's degree in pharmacy, biology, chemistry, pharmacology, or engineering.
• Experience filing PMA supplements and regulatory submissions.
• Knowledge of FDA PMA guidance documents and CFR regulations.
• 3-5 years in quality systems or cross-functional PM.
• Strong communication with internal and external partners.

Responsibilities

• File applications and manage government interactions for regulatory approval.
• Author PMA supplements and related notices.
• Review engineering study protocols and validation reports.
• Review and approve changes for Class III implantable devices.
• Lead and mentor regulatory team members as needed.
• Coordinate with partners to deliver regulatory submissions.
• Prepare agency meetings and pre-meeting submissions.
• Manage change control in line with regulations.

Skills

Regulatory affairs

PMA submissions

FDA CFR knowledge

Quality systems

Project management

Communication skills

Education

Bachelor's degree in pharmacy

Regulatory affairs certification

Job description

Katalyst CRO in North Chicago seeks an experienced Regulatory Affairs Specialist contractor to oversee government filings for complex Class III implantable devices. You will lead PMA-related submissions and ensure CFR compliance across programs, collaborating with engineering, QA, and manufacturing teams.

The role requires 3–5 years of direct regulatory experience, strong document authoring, and a proven track record in PMA approvals.