Director of Regulatory Affairs Jobs in Bethesda, MD
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.
US Regulatory Affairs Manager (US-REMOTE)
- Washington, DC (6 miles from Bethesda, MD)
- 2 days ago
- Washington, DC (6 miles from Bethesda, MD)
- 2 days ago
This Manager will report to the Senior Director Regulatory Affairs and will work remotely with as needed work out of our campus in Thousand Oaks, CA....
Remote WorkRegulatory Affairs Director - Global Regulatory Lead
- Washington, DC (6 miles from Bethesda, MD)
- 2 days ago
- Washington, DC (6 miles from Bethesda, MD)
- 2 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)
- 13 days ago
- Washington, DC (6 miles from Bethesda, MD)
- 13 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)
- 15 days ago
- Arlington, VA (6 miles from Bethesda, MD)
- 15 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)
- 16 days ago
- Tysons, VA (6 miles from Bethesda, MD)
- 16 days ago
The National Automobile Dealers Association (NADA) is seeking a Senior Director, Regulatory Affairs (Environment & Safety) to guide and influence the future of environmental and safety regulations,...
Director/Senior Director, Regulatory Affairs
- Washington, DC (6 miles from Bethesda, MD)
- 16 days ago
- Washington, DC (6 miles from Bethesda, MD)
- 16 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)
- 16 days ago
- Washington, DC (6 miles from Bethesda, MD)
- 16 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)
- 21 days ago
- Rockville, MD (7 miles from Bethesda, MD)
- 21 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. Based in...
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 regulatory...
US Strategic Director - Regulatory Affairs
- Washington, DC (6 miles from Bethesda, MD)
- 24 days ago
- Washington, DC (6 miles from Bethesda, MD)
- 24 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)
- 29 days ago
- Washington, DC (6 miles from Bethesda, MD)
- 29 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...
Director, Regulatory Affairs, Digital Assets
- Washington, DC (6 miles from Bethesda, MD)
- 29 days ago
- Washington, DC (6 miles from Bethesda, MD)
- 29 days ago
This role is for a Director of Regulatory Affairs on the US Government Affairs & Public Policy team with a legal background and deep expertise in financial services policy....
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 Director of Regulatory Affairs Jobs in Bethesda, MD
Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
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Director 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 Director of Regulatory Affairs position
- Clinical Research
- Bioinformatics
- Biology
- Immunology
- Medical Writing
- Drug Development
- Clinical Trials
- Biomedical Engineering
- Drug Discovery
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- 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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