Director of Quality and Regulatory

Director of Quality and Regulatory at LHH Director of Quality and Regulatory at LHH in Highland Park, Illinois Posted in about 23 hours ago.

Type:

full-time

Job Description:

We're partnering with a confidential organization in the pharmaceutical / medical device space seeking a Director of Quality & Regulatory to lead compliance, quality systems, and regulatory strategy across the business. This is a critical leadership role with direct impact on product safety, regulatory readiness, and global quality standards . What You'll Do Lead and optimize the Quality Management System (QMS) in a regulated environment Ensure compliance with

FDA, ISO

(13485), cGMP, and other global regulatory standards Oversee regulatory submissions, audits, and inspections (internal, external, and agency) Drive CAPA, risk management, and continuous improvement initiatives Partner cross-functionally with R D, Manufacturing, and Operations Build and develop a high-performing Quality & Regulatory team Serve as a key leader in inspection readiness and remediation plans What We're Looking For 10+ years of experience in Quality and/or Regulatory leadership Strong background in pharmaceutical and/or medical device environments Deep knowledge of FDA regulations, ISO standards, and cGMP requirements Proven experience leading audits, inspections, and quality systems transformations Demonstrated ability to influence cross-functional stakeholders and executive teams Strategic thinker with a hands-on leadership approach Why This Role? High-impact leadership role with enterprise-wide visibility Opportunity to shape and elevate quality and regulatory strategy Work within a high-growth, regulated environment Competitive compensation + long-term leadership opportunity Experience Preferences 7-10+ years of experience in reliability engineering, maintenance engineering, or asset management within heavy industrial operations

Work Schedule :

On site

Compensation:

$150-199k base

Benefits:

Medical, dental, vision Equal Opportunity Employer/Veterans/Disabled To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.lhh.com/us/en/candidate-privacy The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: The California Fair Chance Act Los Angeles City Fair Chance Ordinance Los Angeles County Fair Chance Ordinance for Employers San Francisco Fair Chance Ordinance