Regulatory Affairs Manager

Katalyst CRO; Mossville (IL); Presencial; USD 140.000 - 190.000; Jornada completa

Descripción de la vacante

Katalyst CRO in the United States is seeking a seasoned Manager of Regulatory Affairs to lead FDA regulatory strategy for medical devices. You will guide submissions, lifecycle management, and cross-functional collaboration with quality, R&D, and clinical teams to ensure compliance and timely approvals.

The role requires deep knowledge of FDA 21 CFR 820, ISO 13485, and related standards, with a track record of successful 510(k) and PMA submissions.

Formación

• Requires strong knowledge of FDA 21 CFR 820 and ISO 13485.
• Minimum 10 years in regulatory affairs for medical devices.
• Proven track record with 510(k) and PMA submissions.
• Excellent communication and leadership skills.
• Experience with eQMS and regulatory audits.

Responsabilidades

• Lead regulatory strategy and submissions for U.S. Class II and III devices.
• Prepare and manage 510(k), PMA supplements, and annual reports.
• Serve as US regulatory lead on cross-functional teams with clinical, quality, and R&D.
• Interpret and apply regulations to product development, labeling, and promotions.
• Monitor regulatory changes and communicate impact to stakeholders.
• Support audits and inspections by regulatory authorities.
• Lead post-market assessments including vigilance and renewals.
• Manage complaint handling with timely investigations and reporting.

Conocimientos

Regulatory strategy

FDA regulatory knowledge

Cross-functional leadership

Regulatory submissions

Educación

Bachelor's degree in engineering, life sciences, pharmacy, or related field

Advanced degree preferred

Herramientas

eQMS

Electronic document control

Descripción del empleo

Job Description

We are seeking a highly experienced and motivated Manager, Regulatory Affairs, to join our growing Regulatory Affairs team. This role is critical to ensuring compliance with US regulatory requirements and supporting the development, approval, and lifecycle management of medical devices. The ideal candidate will possess deep expertise in U.S. FDA regulations, and have a good general understanding of EU MDR, and international standards, and will contribute to strategic regulatory planning and execution.

Responsibilities

• Lead regulatory strategy and submissions for Class II and III medical devices in the U.S.
• Prepare and manage regulatory submissions including 510(k), PMA Supplements, annual reports
• Serve as the US regulatory lead on cross-functional project teams, ensuring alignment with clinical, quality, and R&D functions.
• Interpret and apply regulatory requirements to product development, labeling, and review of advertising and promotional materials.
• Monitor changes in regulatory requirements and communicate impact to internal stakeholders.
• Support audits and inspections by regulatory authorities.
• Lead post-market regulatory assessments and submissions, including periodic reports, vigilance reporting, and regulatory renewals.
• Manage complaint handling activities, ensuring timely investigation, documentation, and regulatory reporting in compliance with applicable standards.

Requirements

• Bachelor's degree in engineering, life sciences, pharmacy, or related field. Advanced degree preferred.
• Minimum 10 years of experience in regulatory affairs within the medical device industry.
• Proven track record of successful submissions to FDA
• In-depth knowledge of FDA 21 CFR 820, ISO 13485, and other applicable standards.
• Strong communication, leadership, and project management skills.
• Experience with eQMS systems and electronic document control preferred