Manager of Regulatory Affairs Jobs in Bethesda, MD
A Manager of Regulatory Affairs in the quality control industry plays a pivotal role in ensuring that the company's products meet all necessary regulatory standards. Their key responsibilities include developing and implementing regulatory strategies, monitoring changes to regulatory guidelines, and ensuring the organization's compliance with these changes. They also engage in the preparation, review, and submission of regulatory documents to regulatory agencies. To effectively execute these responsibilities, they liaise with various stakeholders within and outside the organization, such as product developers, project managers, and regulatory bodies.
Important skills and certifications for a Manager of Regulatory Affairs include strong organizational and project management skills, excellent written and verbal communication skills, as well as a keen eye for detail. Analytical thinking and problem-solving skills are also crucial in this role. Additionally, they should possess relevant certifications such as the Regulatory Affairs Certification (RAC), which is recognized worldwide as the leading credential for regulatory professionals in the healthcare product sector. Before becoming a Manager of Regulatory Affairs, a person may have roles such as a Regulatory Affairs Specialist, Quality Control Analyst, or a Quality Assurance Associate. These roles would provide the necessary exposure and experience in quality control and regulatory affairs needed for the managerial position.
Senior Director, Regulatory Affairs Plastics Industry Association (Plastics)
- Washington, DC (6 miles from Bethesda, MD)
- 4 hours ago
- Washington, DC (6 miles from Bethesda, MD)
- 4 hours ago
Organization: Plastics Industry Association (PLASTICS)Position: Senior Director, Regulatory AffairsReports To: Vice President, Government AffairsLocation: Washington, DC/HybridAre you a regulatory...
Director, Regulatory Affairs, Specialty
- Rockville, MD (7 miles from Bethesda, MD)
- 7 hours ago
- Rockville, MD (7 miles from Bethesda, MD)
- 7 hours ago
Site Name: USA - Pennsylvania - Upper Providence, Cambridge Park Drive, Collegeville TSA, USA - Maryland - Rockville Posted Date: Apr 29 2025 Job Purpose Ensure the development of appropriate...
Regulatory Affairs Director - Oncology
- Gaithersburg, MD (11 miles from Bethesda, MD)
- 20 hours ago
- Gaithersburg, MD (11 miles from Bethesda, MD)
- 20 hours ago
Are you a strategically focussed Regulatory professional and would like to play an integral part in bringing life changing Oncology medicines to patients? If you are please read on! About...
Senior Manager, Regulatory Affairs
- Washington, DC (6 miles from Bethesda, MD)
- 5 days ago
- Washington, DC (6 miles from Bethesda, MD)
- 5 days ago
**Job Overview** We are currently seeking a dynamic, highly motivated, and experienced individual for the position of **Senior Manager, Regulatory Affairs**....
Regulatory Affairs Manager Combination Products
- Washington, DC (6 miles from Bethesda, MD)
- 10 days ago
- Washington, DC (6 miles from Bethesda, MD)
- 10 days ago
HOW MIGHT YOU DEFY IMAGINATION? Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already...
Associate Director, Regulatory Affairs (In Vitro Diagnostics & Companion Diagnostics)
- Washington, DC (6 miles from Bethesda, MD)
- 10 days ago
- Washington, DC (6 miles from Bethesda, MD)
- 10 days ago
Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely...
Regulatory Affairs Director - Global Regulatory Lead
- Washington, DC (6 miles from Bethesda, MD)
- 13 days ago
- Washington, DC (6 miles from Bethesda, MD)
- 13 days ago
Join Amgens Mission of Serving Patients At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all...
Regulatory Affairs Director, Broadband
- Arlington, VA (6 miles from Bethesda, MD)
- 26 days ago
- Arlington, VA (6 miles from Bethesda, MD)
- 26 days ago
NRECA is a unique national trade association providing advocacy, financial services and business support services to over 900 consumer owned electric cooperatives across the country. NRECA...
Senior Director, Regulatory Affairs (Environment & Safety)
- Tysons, VA (6 miles from Bethesda, MD)
- 27 days ago
- Tysons, VA (6 miles from Bethesda, MD)
- 27 days ago
Are you an experienced attorney with a strong passion for environmental, health, and safety regulations, and a commitment to advocating for the automotive and truck dealership industry? The...
Director/Senior Director, Regulatory Affairs
- Washington, DC (6 miles from Bethesda, MD)
- 27 days ago
- Washington, DC (6 miles from Bethesda, MD)
- 27 days ago
CFR 820, ISO 13485, IMDRF, Good Clinical Practice, CAP/CLIA, other quality system standards Strong communication, presentation and interpersonal skills Experience leading cross-functional teams of...
Manager/Senior Manager, Regulatory Affairs
- Washington, DC (6 miles from Bethesda, MD)
- 27 days ago
- Washington, DC (6 miles from Bethesda, MD)
- 27 days ago
CFR 820, ISO 13485, IMDRF, Good Clinical Practice, CAP/CLIA, other quality system standards Strong communication, presentation and interpersonal skills Experience leading cross-functional teams of...
US Strategic Director - Regulatory Affairs
- Washington, DC (6 miles from Bethesda, MD)
- 30+ days ago
- Washington, DC (6 miles from Bethesda, MD)
- 30+ days ago
Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe...
Regulatory Affairs Director, Washington D.C. Hybrid
- Washington, DC (6 miles from Bethesda, MD)
- 30+ days ago
- Washington, DC (6 miles from Bethesda, MD)
- 30+ days ago
Company DescriptionExperian is a global data and technology company, powering opportunities for people and businesses around the world. We help to redefine lending practices, uncover and prevent...
Associate Director, Regulatory Affairs (In Vitro Diagnostics & Companion Diagnostics)
- Bethesda, MD
- 90+ days ago
- Bethesda, MD
- 90+ days ago
Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely...
Demographic Data for Bethesda, MD
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Salary for Manager of Regulatory Affairs Jobs in Bethesda, MD
Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
Highest Education Level
Manager of Regulatory Affairss in Bethesda, MD offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Manager of Regulatory Affairs position
- Medical Terminology
- Clinical Research
- Biology
- Immunology
- Oncology
- Assay Development
- Neurology
- Medical Writing
- Drug Development
- Clinical Trials
- Drug Discovery
- Biotechnology
- Next-Generation Sequencing
- Pharmacovigilance
- Gene Therapy
- Biomarkers
- Internal Audits
- Quality Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Change Control
- Medical Device Sales
- FDA Regulations
- Document Management
- Research and Development
- Resolution
- Product Development
- Engineering
- Strategy Development
- Quality Assurance
- Military Background
- Implementation
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Mentoring
- Collaboration
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Coaching
- Regulations
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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