Director of Regulatory Affairs Jobs
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.
Regulatory Affairs Manager APAC - Diabetes Care (on-site)
- Alameda, CA
- 45+ days ago
- Alameda, CA
- 45+ days ago
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses...
Summary As Associate Director of Regulatory Affairs, you will lead regulatory activities for new product development, labeling changes, promotional requests, and other regulatory submissions in both...
Jubilant HollisterStier LLC, a well-established member of the business community in Spokane, Washington, provides a complete range of services to support the pharmaceutical and biopharmaceutical...
Gestionnaire, Affaires Reglementaires / Manager, Regulatory Affairs
- Montreal, WI
- 1 hour ago
- Montreal, WI
- 1 hour ago
Gestionnaire, Affaires Reglementaires Jubilant HollisterStier, une filiale de Jubilant Pharma Holdings Inc., recrute actuellement un Gestionnaire, Affaires Reglementaires pour rejoindre notre...
Manager Regulatory Affairs Houston, TX, USA Req #1430 Thursday, March 13, 2025 *To access Dayforce at its best, log in from the latest version of Chrome, Safari, Firefox, or Edge. * Boardwalk is a...
Job Description Summary The Global Program Regulatory Manager (GPRM) works with some independence under limited supervision to provide strategic and operational regulatory direction and may...
in class III vascular devices are looking for an experienced Director of Regulatory Affairs to drive regulatory excellence in this field....
A client of mine based in North Carolina are looking for a Regulatory CMC Executive Director that has strong, deep and proven expertise in biological and cell therapy products. The appropriate...
The Manager, Regulatory Affairs supports the Alliance's regulatory advocacy, outreach, and compliance assistance programs by tracking government regulatory activities, analyzing proposals and...
Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the worldfrom the moment of birth...
The Senior Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products....
We continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients.Position Summary:The Executive Director, Regulatory Affairs will develop...
Understands the requirements of FDA 21CFR Part 820, EU MDR, MDSAP, CMDR and ISO 13485 and strong experience with standards management....
Aventiv Technologies – Where your future awaits - YouTube Job Purpose: The Director of Regulatory Affairs manages the Company’s interests before state and federal regulatory agencies, industry groups...
Knix is an award-winning intimate apparel and activewear brand that is re-inventing intimates for real life. Through our innovative products and our engaged community, we are empowering people...
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Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
Highest Education Level
Director of Regulatory Affairss 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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