Regulatory Affairs Specialist Jobs in Clarksburg, 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.
- Mc Lean, VA (20 miles from Clarksburg, MD)
- 1 day ago
- Mc Lean, VA (20 miles from Clarksburg, MD)
- 1 day ago
The Sr IT Compliance Analyst is a key member of the IT Compliance program, responsible for leading assigned compliance initiatives, in support of the company's organizational objectives. The Sr IT...
Regulatory Affairs Coordinator (RAC) (Entry Senior Level)
- Sterling, VA (18 miles from Clarksburg, MD)
- 1 day ago
- Sterling, VA (18 miles from Clarksburg, MD)
- 1 day ago
Participates in Data Safety Monitoring Committee (DSMC) internal audits. Updates database with regulatory submission and approval dates....
SAP NS2 Senior Information Security Compliance Analyst
- Herndon, VA (20 miles from Clarksburg, MD)
- 19 days ago
- Herndon, VA (20 miles from Clarksburg, MD)
- 19 days ago
Enhance internal audit functions to increase process efficiency. Works in a fast-paced environment with managing several projects. Track risk response action plans to completion....
- Ashburn, VA (18 miles from Clarksburg, MD)
- 27 days ago
- Ashburn, VA (18 miles from Clarksburg, MD)
- 27 days ago
Who are we? Equinix is the world's digital infrastructure company, operating over 260 data centersacross the globe. Digital leaders harness Equinix's trusted platform to bring together and...
Retirement Plans Compliance Analyst (Performance Management and Data Analyst I/II, Grade 21/25)
- Rockville, MD (14 miles from Clarksburg, MD)
- 29 days ago
- Rockville, MD (14 miles from Clarksburg, MD)
- 29 days ago
Retirement Plans Compliance Analyst (Performance Management and Data Analyst I/II, Grade 21/25) Salary $92,075.00 - $149,112.00 Annually Location 101 Monroe St Rockville MD 20850 USA Job Type...
- Chevy Chase, MD (22 miles from Clarksburg, MD)
- 30+ days ago
- Chevy Chase, MD (22 miles from Clarksburg, MD)
- 30+ days ago
GEICO Actuarial Pricing Compliance team works in a fast paced environment and is instrumental in keeping GEICO in compliance with current laws and protecting our reputation. Successful candidates...
- Tysons Corner, VA (21 miles from Clarksburg, MD)
- 90+ days ago
- Tysons Corner, VA (21 miles from Clarksburg, MD)
- 90+ days ago
The Senior IT Compliance Analyst is a key member of the IT Compliance program, responsible for leading assigned compliance initiatives, in support of the company's organizational objectives. The...
Demographic Data for Clarksburg, MD
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Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Clarksburg, MD
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Clarksburg, MD offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Finance
- Medicaid
- Flexibility
- Call Center Experience
- Medicare
- Internal Control
- Management Reporting
- Fraud Investigation
- Reimbursement
- Institutional Review Board
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Medical Device Sales
- Business Processes
- FDA Regulations
- Document Management
- Microsoft Visio
- Root Cause Analysis
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Risk Management
- Strategy Development
- Military Background
- Implementation
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Data Analysis
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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