Top 1506 Office representative Jobs in Newberg Or

Regulatory Specialist
DCI —Newberg, OR
- $76,960 - $123,801 a year
- Full-time
- Background check
- Mid-level
- Office
- Health insurance
- Dental insurance
Quick Apply
Contact Center Representative
NW Priority Credit Union —Beaverton, OR
- $21 - $28 an hour
- Overtime
- Analysis skills
- Travel
- Ability to sit for extended periods
Administrative Coordinator - Accounts Receivable
CampusPoint —Lake Oswego, OR
- $19.23 an hour
- Contract
- Hybrid work
- Background check
- Microsoft Excel
- Salesforce
- Health savings account
- Health insurance
Quick Apply
Customer Service & Sales Representative
Farmers Insurance - District 24 —Newberg, OR
- $20 - $22 an hour
- Full-time
- Spanish
- Microsoft Outlook
- Computer literacy
- Paid time off
- Opportunities for advancement
Quick Apply
8d
CSR Specialist II
Express Employment —Newberg, OR
- $25 - $30 an hour
- Full-time
- Microsoft Outlook
- 5 years
- Word processing
- Flexible schedule
Quick Apply
3d
Patient Access Representative
Legacy Health —Tualatin, OR
- $22.32 - $31.90 an hour
- Part-time
- Hospital
- Writing skills
- High school diploma or GED
Senior Project Manager/Estimator
Siegmund Excavation & Construction —Portland, OR
- Weekends as needed
- 7 years
- Microsoft Excel
- Construction site
- Profit sharing
- Paid holidays
Quick Apply
Financial Advisor - Tualatin, OR
COUNTRY Financial —Tualatin, OR
- Full-time
- CPA
- Mid-level
- Office
Durable Medical Equipment Representative/Orthotic Fitter
Synergy Medical Systems —Portland, OR
- $3,500 - $4,000 a month
- 8 hour shift
- Customer service
- HIPAA
- Ability to lift 50 pounds
- Health insurance
- Dental insurance
Quick Apply
Fire Suppression Technician (Commercial Kitchen Systems)
Summit Fire & Security —Portland, OR
- $25 - $35 an hour
- Full-time
- Background check
- Clean driving record
- Customer service
- Paid holidays
- Disability insurance
Outside Sales Representative - Building Materials
Hardwoods Specialty Products —Wilsonville, OR
- $60,000 - $70,000 a year
- Full-time
- Microsoft PowerPoint
- Microsoft Word
- Background check
- Fuel card
- Health insurance
Quick Apply
1d
Financial Advisor - Hillsboro, OR
COUNTRY Financial —Hillsboro, OR
- Full-time
- CPA
- Mid-level
- Office
CDL Truck Driver
PPG —Salem, OR
- From $22.94 an hour
- Full-time
- Hazmat Endorsement
- Computer literacy
- CDL A
Quick Apply
Senior Manager, OSP Construction
Ziply Fiber —Beaverton, OR
- $108,682 - $158,178 a year
- Microsoft Word
- Background check
- Microsoft Excel
- Health insurance
- Dental insurance
Quick Apply
Commercial HVAC Maintenance Sales Rep
COMFORT FLOW HEATING CO —Milwaukie, OR
- Clean driving record
- Marketing
- Mid-level
Quick Apply
6d
Project Manager, Senior Manager
VVA Drees & Sommer —Beaverton, OR
- $165,000 - $180,000 a year
- Full-time
- 5 years
- Bachelor of Science
- Research
- Health savings account
- Health insurance
Quick Apply
6d
Behavior Professional: Independent (BPI) VALLEY BILINGUAL
SilverNail NW LLC —Salem, OR
- $42 - $47 an hour
- Contract
- Hybrid work
- Background check
- 18 years or older
- Working with individuals with developmental disabilities
- Paid time off
- Work from home
Quick Apply
Sales Representative - Wholesale Produce
Caruso Produce —Canby, OR
- $70,000 - $90,000 a year
- Full-time
- Background check
- Spanish
- Microsoft Excel
- Mileage reimbursement
- Health insurance
Quick Apply
Channel Sales Manager
Fisher Farms —Gaston, OR
- $65,000 - $70,000 a year
- Full-time
- Background check
- Spanish
- Sales
- Health insurance
- Dental insurance
Quick Apply
Enterprise Account Executive
Ziply Fiber —Beaverton, OR
- $60,000 - $100,000 a year
- Background check
- 7 years
- Writing skills
- Health insurance
- Dental insurance
Quick Apply
2d

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Regulatory Specialist

DCI -
Newberg, OR

Quick Apply

Job Details

Full-time
$76,960 - $123,801 a year

Benefits

Health insurance
Dental insurance
401(k)
Flexible spending account
Paid time off
Vision insurance
401(k) matching
Flexible schedule
Life insurance

Qualifications

ISO certification process
Accreditation standards (regulatory compliance area)
Bachelor's degree
Quality risk management
Product development
Continuous improvement
Regulatory/legal compliance standards in production
Biomedical regulatory compliance
Training & development
Manufacturing
ISO 13485
FDA regulations

Full Job Description

The Regulatory Specialist is responsible for coordinating and maintaining documentation to support global regulatory compliance and quality system objectives. This includes managing international product registrations, preparing regulatory submissions, conducting internal audits, and maintaining QMS documentation. The Regulatory Specialist collaborates with cross-functional teams including Engineering, Quality, Document Control, and Customer Service to ensure regulatory files and product records are accurate, audit-ready, and aligned with current regulations (FDA, EU MDR, ISO 13485, etc.).

Primary Duties and Responsibilities: (include, but not limited to):

Interpret and apply regulatory requirements for domestic and international markets (e.g., FDA, EU MDR, Health Canada, TGA, Japan).
Prepare, submit, and maintain regulatory documentation including 510(k)s, CE Technical Files, and Certificates for Foreign Governments.
Manage global registration and listing activities; maintain accurate tracking of product approvals and renewals.
Maintain communication with regulatory authorities, notified bodies, and international representatives (e.g., sponsors, MAHs), in accordance with DCI QMS SOPs.
Review and assess Engineering Change Orders (ECOs) for potential regulatory impact or classification as significant changes.
Assist with the development and review of product labeling (e.g., IFUs, package labeling, UDI data) to ensure global compliance.
Monitor evolving regulations and standards (e.g., ISO 13485, ISO 14971, MDSAP) and assess their impact on business operations.
Maintain and update quality management system documentation (Quality Manual, SOPs, procedures, templates).
Develop and maintain QMS training documentation and ensure training plans are current and audit ready.
Coordinate and conduct internal audits; issue audit reports and track corrective actions.
Participate in third-party audits and FDA inspections, providing documentation and supporting responses to findings.
Support post-market surveillance (PMS) activities including complaints trending, CAPA coordination, adverse event reporting, and recall documentation.
Participate in risk management activities per ISO 14971 and in product development reviews to ensure compliance with applicable requirements.
Provide cross-functional training and guidance on regulatory and QMS-related topics.
Maintain audit-ready technical documentation and regulatory files throughout the product lifecycle.
Support or lead continuous improvement projects related to regulatory or QMS compliance.
Perform additional duties as assigned by the Quality Assurance and Regulatory Affairs Manager.

Educational and Skill Requirements:

Knowledge and experience with applicable FDA, Health Canada, ISO, MDD requirements (Legacy Products-Article 120 compliance), MDR Regulations.
ISO 14971:2019 Risk management.
Certification to ISO 13485:2016 and MDSAP
Ability to support Product Development projects.
Bachelor’s degree or a minimum of 10 years’ experience in the medical device manufacturing industry.
Physical Requirements:
Must be able for sit for long periods of time at a computer workstation.

Equipment Used:

Personal Computer
Microsoft Office Suite

Work Schedule:

Ability to work flexible hours, with additional time as needed.
Less than 1% unplanned absenteeism is expected.
No more than 40 unexcused hours per calendar year

Pay: $76,960.00 - $123,801.00 per year

Benefits:

401(k)
401(k) matching
Dental insurance
Flexible spending account
Health insurance
Life insurance
Paid time off
Vision insurance

Experience:

medical device manufacturing industry: 10 years (Preferred)

Work Location: In person

Quick Apply

Refine Your Search

office representative jobs in newberg or

Regulatory Specialist

Contact Center Representative

Administrative Coordinator - Accounts Receivable

Customer Service & Sales Representative

CSR Specialist II

Patient Access Representative

Senior Project Manager/Estimator

Financial Advisor - Tualatin, OR

Durable Medical Equipment Representative/Orthotic Fitter

Fire Suppression Technician (Commercial Kitchen Systems)

Outside Sales Representative - Building Materials

Financial Advisor - Hillsboro, OR

CDL Truck Driver

Senior Manager, OSP Construction

Commercial HVAC Maintenance Sales Rep

Project Manager, Senior Manager

Behavior Professional: Independent (BPI) VALLEY BILINGUAL

Sales Representative - Wholesale Produce

Channel Sales Manager

Enterprise Account Executive

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