Regulatory Affairs Specialist Jobs in Gainesville, VA
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.
Mortgage Licensing and Compliance Analyst
- Reston, VA (18 miles from Gainesville, VA)
- 10 hours ago
- Reston, VA (18 miles from Gainesville, VA)
- 10 hours ago
Guidance Residential, LLC is a strong, growing company that specializes in residential mortgage lending. Our team members are a vital strength in our ability to grow and continue to serve our...
Regulatory Compliance Analyst (Mid-Level)- DIGITAL
- Vienna, VA (22 miles from Gainesville, VA)
- 1 day ago
- Vienna, VA (22 miles from Gainesville, VA)
- 1 day ago
Job Title: Mid-Level Regulatory Compliance Analyst Location: Vienna, VA or Pensacola, FL Hybrid: onsite 2 days a week or 8 days a month in either Vienna or Pensacola Hours: Monday - Friday, 8:00...
- Vienna, VA (22 miles from Gainesville, VA)
- 1 day ago
- Vienna, VA (22 miles from Gainesville, VA)
- 1 day ago
Top 3 Required Skills: Regulatory Compliance minimum 5 years of experience Risk Management minimum 5 years of experience Analytical Thinking Top 3 Desired Skills: NCCO Certification (strong...
- Mc Lean, VA (24 miles from Gainesville, VA)
- 2 days ago
- Mc Lean, VA (24 miles from Gainesville, VA)
- 2 days 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 Gainesville, VA)
- 2 days ago
- Sterling, VA (18 miles from Gainesville, VA)
- 2 days 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 (17 miles from Gainesville, VA)
- 21 days ago
- Herndon, VA (17 miles from Gainesville, VA)
- 21 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....
ActioNet, Inc. Careers - IT Quality Compliance Analyst
- Vienna, VA (22 miles from Gainesville, VA)
- 45+ days ago
- Vienna, VA (22 miles from Gainesville, VA)
- 45+ days ago
Ensure compliance with CMMI ML4, ISO 9001, ISO 20000, and ISO 27001 through internal audits and process evaluations....
Regulatory Affairs Coordinator
- Fairfax, VA (11 miles from Gainesville, VA)
- 45+ days ago
- Fairfax, VA (11 miles from Gainesville, VA)
- 45+ days ago
Overview Are you looking for a career and not just a job in the Medical field? Virginia Cancer Specialists, affiliated with McKesson Specialty Health and US Oncology, a leader in cancer care, is...
Government Compliance Analyst IV
- Chantilly, VA (11 miles from Gainesville, VA)
- 45+ days ago
- Chantilly, VA (11 miles from Gainesville, VA)
- 45+ days ago
Overview Arcfield was purpose-built to protect the nation and its allies through innovations in digital transformation, space mission engineering and launch assurance, miniaturized sensors and...
Government Compliance Analyst III
- Chantilly, VA (11 miles from Gainesville, VA)
- 45+ days ago
- Chantilly, VA (11 miles from Gainesville, VA)
- 45+ days ago
Overview Arcfield was purpose-built to protect the nation and its allies through innovations in digital transformation, space mission engineering and launch assurance, miniaturized sensors and...
- Tysons Corner, VA (24 miles from Gainesville, VA)
- 90+ days ago
- Tysons Corner, VA (24 miles from Gainesville, VA)
- 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 Gainesville, VA
Moving to Gainesville, VA? Find some basic demographic data about Gainesville, VA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Gainesville, VA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Gainesville, VA 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
- Corrective Actions & Preventive Actions
- ISO 13485
- Medical Device Sales
- Business Processes
- FDA Regulations
- Document Management
- Microsoft Visio
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Risk Management
- Strategy Development
- Implementation
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Data Analysis
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Sales
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
Other Career Titles
Here are some other career titles that require similar skills
Regulatory Affairs Specialist Related Career Advice Articles
Top Skills and Quality Control Training You Need to Get Promoted
Ready to take your quality control career to the next level? Seek out quality control training for these highly desired skills for quality control jobs.
Read article »