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.
Regulatory Affairs Manager Combination Products
- Washington, DC (6 miles from Bethesda, MD)
- 5 hours ago
- Washington, DC (6 miles from Bethesda, MD)
- 5 hours 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)
- 7 hours ago
- Washington, DC (6 miles from Bethesda, MD)
- 7 hours 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...
US Regulatory Affairs Manager (US-REMOTE)
- Washington, DC (6 miles from Bethesda, MD)
- 3 days ago
- Washington, DC (6 miles from Bethesda, MD)
- 3 days ago
HOW MIGHT YOU DEFY IMAGINATION? You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and...
Remote WorkRegulatory Affairs Director - Global Regulatory Lead
- Washington, DC (6 miles from Bethesda, MD)
- 3 days ago
- Washington, DC (6 miles from Bethesda, MD)
- 3 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...
- Washington, DC (6 miles from Bethesda, MD)
- 12 days ago
- Washington, DC (6 miles from Bethesda, MD)
- 12 days ago
About Us\: Mercedes-Benz North America Corporation is a US subsidiary of Mercedes-Benz Group AG, one of the most successful automotive companies. With Mercedes-Benz AG, the Group is one of the...
Regulatory Affairs Manager CMC
- Washington, DC (6 miles from Bethesda, MD)
- 14 days ago
- Washington, DC (6 miles from Bethesda, MD)
- 14 days ago
Regulatory Affairs Manager CMC Amgen - 4.0 Washington, DC Job Details $112,345 - $143,224 a year 1 day ago Benefits Disability insurance Health insurance Dental insurance Flexible spending account...
Regulatory Affairs Director, Broadband
- Arlington, VA (6 miles from Bethesda, MD)
- 16 days ago
- Arlington, VA (6 miles from Bethesda, MD)
- 16 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)
- 17 days ago
- Tysons, VA (6 miles from Bethesda, MD)
- 17 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)
- 17 days ago
- Washington, DC (6 miles from Bethesda, MD)
- 17 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)
- 17 days ago
- Washington, DC (6 miles from Bethesda, MD)
- 17 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...
Senior Manager Regulatory Affairs CMC
- Rockville, MD (7 miles from Bethesda, MD)
- 22 days ago
- Rockville, MD (7 miles from Bethesda, MD)
- 22 days ago
MEET have partnered with one of our esteemed biotech clients focused in the rare disease space as they seek a tenured Senior Manager Regulatory Affairs CMC to join their wonderful team....
Senior Director, Regulatory Affairs
- Washington, DC (6 miles from Bethesda, MD)
- 22 days ago
- Washington, DC (6 miles from Bethesda, MD)
- 22 days ago
Organization: Plastics Industry Association (PLASTICS) Position: Senior Director, Regulatory Affairs Reports To: Vice President, Government Affairs Location: Washington, DC/Hybrid Are you a...
US Strategic Director - Regulatory Affairs
- Washington, DC (6 miles from Bethesda, MD)
- 25 days ago
- Washington, DC (6 miles from Bethesda, MD)
- 25 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...
Government Relations, Regulatory Affairs Director, Tax Policy and Finance
- Arlington, VA (6 miles from Bethesda, MD)
- 30+ days ago
- Arlington, VA (6 miles from Bethesda, MD)
- 30+ days ago
Position Summary: This position is responsible for collaborating with professionals across NRECA's Government Relations Regulatory Unit, which is focused on electric cooperative advocacy before...
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...
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.
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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
- Clinical Research
- Bioinformatics
- Biology
- Immunology
- Medical Writing
- Drug Development
- Clinical Trials
- Drug Discovery
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- Biomarkers
- Internal Audits
- Quality Management Systems
- Quality Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Change Control
- Good Clinical Practice
- Microbiology
- Medical Device Sales
- FDA Regulations
- Document Management
- Research and Development
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Risk Management
- Strategy Development
- Quality Assurance
- Process Improvement
- Implementation
- Auditing
- Written Communication
- Verbal Communication
- Strategic Planning
- Documentation
- Mentoring
- Collaboration
- Reporting
- Education Experience
- Interpersonal Skills
- Coaching
- Bachelor's Degree
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Teamwork
- Staff Supervision
- Organization
- Research Skills
- Leadership
- Communication Skills
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