Top 2 Compliance manager Jobs in Peoria, Il

Regulatory Affairs Manager
Katalyst Healthcares & Life Sciences —Mossville, IL
- Contract
- Engineering
- Senior level
- Leadership
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Regulatory Affairs Manager
Katalyst Healthcares & Life Sciences —Mossville, IL
Bachelor's degree in engineering, life sciences, pharmacy, or related field. Serve as the US regulatory lead on cross-functional project teams, ensuring…
Quick Apply

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Senior Manager, Corporate Compliance
CVS Health —New Albany, OH
Track, analyze, research, interpret, communicate and monitor applicable CMS and state regulations and government contract requirements to develop…
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Provider Compliance Manager (Medicaid Health Systems Administrator 1)
State of Ohio - Medicaid —Columbus, OH
Or, in order to operate a state vehicle, you must have a valid driver's license from state of residence. If position oversees assessment or reassessment of…
$40.40 an hour
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Regulatory Affairs Manager

Katalyst Healthcares & Life Sciences -
Mossville, IL

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Job Details

Contract

Qualifications

FDA submissions
ISO standards
Leading team collaboration initiatives
Biomedical regulatory compliance
Project leadership

Full Job Description

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

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Regulatory Affairs Manager

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