Regulatory Affairs Specialist Jobs in Woodinville, WA
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.
- Issaquah, WA (19 miles from Woodinville, WA)
- 1 day ago
- Issaquah, WA (19 miles from Woodinville, WA)
- 1 day ago
Regulatory Affairs Specialist ID: 551281 Posted: 6/12/2025 Location: Issaquah, WA Category: Admin - Administrative Job Type: Temporary Duration: 3 - 6 Months Description Are you an Regulatory Affairs...
Regulatory Affairs Specialist - China NMPA
- Issaquah, WA (19 miles from Woodinville, WA)
- 2 days ago
- Issaquah, WA (19 miles from Woodinville, WA)
- 2 days ago
Our client is currently seeking a Regulatory Affairs Specialist - China NMPA for a 3 - 6 month contract....
Remote Work- Issaquah, WA (19 miles from Woodinville, WA)
- 2 days ago
- Issaquah, WA (19 miles from Woodinville, WA)
- 2 days ago
REGULATORY AFFAIRS SPECIALIST IN ISSAQUAH, WA, USA!...
Sr Regulatory Compliance Specialist - 250000008C
- Kirkland, WA (7 miles from Woodinville, WA)
- 3 days ago
- Kirkland, WA (7 miles from Woodinville, WA)
- 3 days ago
Sr Regulatory Compliance Specialist - 250000008C Nintendo of America Inc. - Kirkland, WA Posted: 6/12/2025 - Expires: 9/10/2025 Job ID: 290357600 Apply Now I have already applied Save Job Print...
Regulatory Affairs Specialist - China NMPA (Ultrasound Imaging)
- Issaquah, WA (19 miles from Woodinville, WA)
- 4 days ago
- Issaquah, WA (19 miles from Woodinville, WA)
- 4 days ago
Overlap with China hours; Pacific Time Zone preferred Description: Job Summary: We are seeking a Regulatory Affairs Specialist (Contractor) with hands-on experience in China NMPA registration for ultrasound...
Sr Regulatory Compliance Specialist
- Redmond, WA (6 miles from Woodinville, WA)
- 4 days ago
- Redmond, WA (6 miles from Woodinville, WA)
- 4 days ago
Nintendo of America Inc. About Nintendo of America\: From the launch of the Nintendo Entertainment System™ more than 30 years ago, Nintendo’s mission has been to create smiles through unique...
Regulatory Compliance Specialist
- Seattle, WA (14 miles from Woodinville, WA)
- 4 days ago
- Seattle, WA (14 miles from Woodinville, WA)
- 4 days ago
Regulatory Compliance Specialist BlueCross BlueShield of South Carolina life insurance, paid time off, tuition assistance, 401(k) United States, Washington, Seattle Jun 07, 2025 Summary The...
Compliance Analyst II - Marketing
- Everett, WA (15 miles from Woodinville, WA)
- 7 days ago
- Everett, WA (15 miles from Woodinville, WA)
- 7 days ago
Compliance Analyst II - Marketing Fully Remote United States Compliance Job Type Full-time Description ABOUT US Coastal Community Bank is a leader in Banking with strong financial infrastructure...
Remote WorkMedicare Compliance Analyst II or III
- Renton, WA (22 miles from Woodinville, WA)
- 8 days ago
- Renton, WA (22 miles from Woodinville, WA)
- 8 days ago
Medicare Compliance Analyst II or III Work from Home within Oregon, Washington, Idaho or Utah Build a career with purpose. Join our Cause to create a person-focused and economically sustainable...
Remote Work- Renton, WA (22 miles from Woodinville, WA)
- 8 days ago
- Renton, WA (22 miles from Woodinville, WA)
- 8 days ago
Compliance Analyst I or II Work from home within Oregon, Washington, Idaho or Utah Build a career with purpose. Join our Cause to create a person-focused and economically sustainable health care...
Remote Work- Seattle, WA (14 miles from Woodinville, WA)
- 8 days ago
- Seattle, WA (14 miles from Woodinville, WA)
- 8 days ago
Prepares, facilitates, coordinates, and submits documentation required by federal, state and local regulations and institutional requirements relating to the conduct of research. This includes...
- Clyde Hill, WA (11 miles from Woodinville, WA)
- 8 days ago
- Clyde Hill, WA (11 miles from Woodinville, WA)
- 8 days ago
Company Information PACCAR is a Fortune 500 company established in 1905. PACCAR Inc is recognized as a global leader in the commercial vehicle, financial, and customer service fields with...
- Everett, WA (15 miles from Woodinville, WA)
- 9 days ago
- Everett, WA (15 miles from Woodinville, WA)
- 9 days ago
As a Fluke **Compliance Analyst**, you will be a member of Flukes global legal team and work in partnership with our parent company, Fortive, to support and enhance our culture of ethics and...
- Clyde Hill, WA (11 miles from Woodinville, WA)
- 9 days ago
- Clyde Hill, WA (11 miles from Woodinville, WA)
- 9 days ago
Smartsheet is a tech company with a human story to tell. We're here to empower teams to manage projects, automate workflows, and rapidly build new secure solutions, using simple no-code tools....
Remote WorkSenior Regulatory Compliance Analyst - NERC / WECC
- Clyde Hill, WA (11 miles from Woodinville, WA)
- 11 days ago
- Clyde Hill, WA (11 miles from Woodinville, WA)
- 11 days ago
Puget Sound Energy is looking to grow our community with top talented individuals like you! With our rapidly growing, award winning energy efficiency programs, our pathway to an exciting and...
Demographic Data for Woodinville, WA
Moving to Woodinville, WA? Find some basic demographic data about Woodinville, WA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Woodinville, WA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Woodinville, WA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Corrective Actions & Preventive Actions
- Medical Device Sales
- Business Processes
- FDA Regulations
- Resolution
- Standard Operating Procedures
- Product Development
- Affirmative Action
- Engineering
- Risk Management
- Military Background
- Analytical Skills
- Implementation
- Auditing
- Investigation
- Verbal Communication
- Writing Skills
- Data Analysis
- Written Communication
- Collaboration
- Documentation
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Sales
- Microsoft Excel
- Microsoft Word
- Time Management
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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