Director of Regulatory Affairs Jobs in Illinois
The Director of Regulatory Affairs in the quality control industry plays an essential role in ensuring that the company's products meet all regulatory standards and compliance requirements. This individual oversees the development and implementation of regulatory strategies for new and existing products, supervises the preparation of regulatory submissions, and maintains communication with regulatory authorities. They also monitor changes in regulations, interpret these updates for relevant departments within the company, and implement necessary changes to maintain compliance. They are responsible for setting the company's standards for quality, safety, and efficacy.
To excel in this role, one should possess excellent analytical skills, strategic thinking, and strong leadership abilities. A deep understanding of regulatory guidelines, ability to interpret complex regulations, and excellent communication skills are essential. They should have a degree in a relevant field, along with certifications such as Regulatory Affairs Certification (RAC), Certified Quality Auditor (CQA), and Certified Quality Engineer (CQE). Prior to becoming a Director of Regulatory Affairs, individuals might have roles such as Regulatory Affairs Specialist, Regulatory Affairs Manager, or Quality Control Manager.
13485, IMDRF, Good Clinical Practice, CAP/CLIA, other quality system standards Strong communication, presentation and interpersonal skills Experience leading cross-functional teams of subject matter...
Remote WorkManager, Regulatory Affairs Submission Management (Onsite or Remote)
- North Chicago, IL
- 8 days ago
- North Chicago, IL
- 8 days ago
Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive...
, Regulatory Affairs and 8+ years for a Director, Regulatory Affairs Previous CRO or Consulting experience highly preferred #LI-LB1 #LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer...
Remote WorkDirector of Regulatory Affairs, Science and Technology Organization
- Chicago, IL
- 12 days ago
- Chicago, IL
- 12 days ago
at GE HealthCare in Chicago, Illinois, United States Job Description Job Description Summary In this role you will provide strategic regulatory leadership to the Science and Technology...
Senior Manager, Regulatory Affairs (Strategy and CMC)
- Lake Zurich, IL
- 12 days ago
- Lake Zurich, IL
- 12 days ago
All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your...
at Silliker, Inc in Chicago, Illinois, United States Job Description Regulatory Affairs Manager - Pet Food Remote Regular MERIEUX NUTRISCIENCES As a trusted partner, our Public Health mission is...
Manager, Regulatory Affairs Company: Bausch + Lomb Location: Springfield, IL Date Posted: 2/25/25, 4:26 AM Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to...
Mgr, Regulatory Affairs Pharma - HealthCanada Company: Fresenius Medical Care North America Location: Chicago, IL Date Posted: 2/14/25, 3:54 AM PURPOSE AND SCOPE: Ensure overall (other than...
Remote WorkRegulatory Affairs Director About the job Regulatory Affairs Director Regulatory Affairs Director Join a leading global organization as a Regulatory Affairs Director, shaping regulatory strategies across...
Strong knowledge/application of US FDA regulations, Health Canada regulations, EU/Brexit regulations, Japan (MHLW) regulations, PMDA, Prop 65, guidance documents and validation requirements....
- North Chicago, IL
- 30+ days ago
- North Chicago, IL
- 30+ days ago
The Director Regulatory Affairs Global Regulatory Lead, Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain market approval for product...
Manager, Regulatory Affairs US Advertising & Promotion, Oncology
- North Chicago, IL
- 30+ days ago
- North Chicago, IL
- 30+ days ago
Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive...
Future Opportunities - Join Our Talent Pipeline for Director Regulatory Affairs, Global Regulatory
- North Chicago, IL
- 45+ days ago
- North Chicago, IL
- 45+ days ago
The Director Regulatory Affairs Global Regulatory Lead, Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain market approval for product...
system....
Thorough understanding of FDA, Health Canada regulations and requirements for in vitro diagnostic devices (21 CFR 820, ISO 13485, ISO 14971, IEC 62304, CMDR)....
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Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
Highest Education Level
Director of Regulatory Affairss in Illinois offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Director of Regulatory Affairs position
- Clinical Research
- Biology
- Immunology
- Oncology
- Assay Development
- Medical Writing
- Drug Development
- Neuroscience
- Clinical Trials
- Drug Discovery
- Biotechnology
- Infectious Disease
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- Biomarkers
- Quality Systems
- Quality Management Systems
- 21 CFR 820
- GxP
- ICH Guidelines
- ISO 13485
- Change Control
- Good Clinical Practice
- Microbiology
- Medical Device Sales
- FDA Regulations
- Document Management
- Research and Development
- Resolution
- Standard Operating Procedures
- Engineering
- Product Development
- Strategy Development
- Quality Assurance
- Implementation
- Military Background
- Auditing
- Mentoring
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- English
- Regulations
- Policy Development
- Project Management
- Microsoft Office
- Microsoft Excel
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Leadership
- Communication Skills
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