Regulatory Affairs Specialist Jobs in Keizer, OR
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.
Remote IT Quality Assurance and Compliance, Analyst
- Salem, OR (4 miles from Keizer, OR)
- 6 days ago
- Salem, OR (4 miles from Keizer, OR)
- 6 days ago
Carrington Remote IT Quality Assurance and Compliance, Analyst in Salem , Oregon Come join our amazing team and work remote from home! What you'll do: Responsible for the timely and accurate...
Remote WorkGrant/Contracts Compliance Analyst
- Salem, OR (4 miles from Keizer, OR)
- 6 days ago
- Salem, OR (4 miles from Keizer, OR)
- 6 days ago
GENERAL STATEMENT OF DUTIES Provides technical expertise and coordinates the planning, development, oversight, and implementation of grant and contracting policy, practice, and process countywide....
Compliance Analyst Sr--Medical Pharmacy Specialty/Medicare Part B- REMOTE
- Salem, OR (4 miles from Keizer, OR)
- 11 days ago
- Salem, OR (4 miles from Keizer, OR)
- 11 days ago
Our work matters. We help people get the medicine they need to feel better and live well. We do not lose sight of that. It fuels our passion and drives every decision we make. Job Posting Title...
Remote Work- Wilsonville, OR (22 miles from Keizer, OR)
- 13 days ago
- Wilsonville, OR (22 miles from Keizer, OR)
- 13 days ago
Be visionary Teledyne Technologies Incorporated provides enabling technologies for industrial growth markets that require advanced technology and high reliability. These markets include aerospace...
Information Security & Compliance Analyst (12 mo. contract)
- Salem, OR (4 miles from Keizer, OR)
- 45+ days ago
- Salem, OR (4 miles from Keizer, OR)
- 45+ days ago
Management and Environmental Management....
Demographic Data for Keizer, OR
Moving to Keizer, OR? Find some basic demographic data about Keizer, OR below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Keizer, OR
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Keizer, OR offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Analytical Skills
- Filing
- Financial Services
- Mortgage Processing
- Reimbursement
- Juris Doctor
- Internal Audits
- Quality Systems
- 21 CFR 820
- ISO 9001
- ICH Guidelines
- ISO 13485
- ISO 14001
- Quality Management
- Process Controls
- Medical Device Sales
- Business Processes
- FDA Regulations
- Microsoft Visio
- Standard Operating Procedures
- Engineering
- Product Development
- Affirmative Action
- Risk Management
- Quality Assurance
- Process Improvement
- Implementation
- Military Background
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Regulations
- Microsoft PowerPoint
- Policy Development
- Project Management
- Microsoft Office
- Microsoft Excel
- Problem Solving
- Time Management
- Teamwork
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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