Top 13 regulatory affairs manager Jobs in bellevue wa

Medical Device Regulatory Affairs & Clinical Evaluation Manager
Global Regulatory Writing & Consulting (GLOBAL) —Bellevue, WA
- Full-time
- Microsoft Excel
- 5 years
- English
Regulatory Response Case Manager, Governance and External Affairs
Amazon.com Services LLC —Bellevue, WA
- $109,000 - $163,900 a year
- Full-time
- 5 years
- Office
- Master's degree
- AD&D insurance
- Health insurance
14d
Director of Environmental Affairs
NorthStar Energy Shared Services —Seattle, WA
- $156,175 - $234,262 a year
- Full-time
- Engineering
- 11+ years
- Travel
- AD&D insurance
- Disability insurance
Delivery Lead, Stratgic Perfom
TriWest Healthcare Alliance —Seattle, WA
- $134,000 - $141,000 a year
- Full-time
- 7 years
- Presentation skills
- Bachelor's degree
- AD&D insurance
- Disability insurance
14d
Sr. Complaint Analyst
OSI Systems, Inc. —Snoqualmie, WA
- $100,000 - $130,000 a year
- Full-time
- Hybrid work
- 7 years
- Engineering
- Mid-level
- Paid jury duty
- Health savings account
7d
Economic Development Manager
Puget Sound Energy —Bothell, WA
- $82,000 - $136,300 a year
- 5 years
- Analysis skills
- Accounting
- AD&D insurance
- Paid holidays
Sr. Complaint Analyst
OSI Systems, Inc —Snoqualmie, WA
- $100,000 - $130,000 a year
- Full-time
- Hybrid work
- 7 years
- Engineering
- Mid-level
- Paid jury duty
- Health savings account
6d
Compliance Specialist, Product Compliance, AWS Global Trade & Product Compliance
Amazon Web Services, Inc. —Seattle, WA
- $102,000 - $178,400 a year
- Full-time
- PMP
- Master's degree
- Bachelor's degree
- AD&D insurance
- Health insurance
5d
Sr. Compliance Specialist, AWS Global Trade & Product Compliance
Amazon Web Services, Inc. —Seattle, WA
- $119,300 - $229,700 a year
- Full-time
- PMP
- 5 years
- Master's degree
- AD&D insurance
- Health insurance
1d

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Medical Device Regulatory Affairs & Clinical Evaluation Manager

Global Regulatory Writing & Consulting (GLOBAL)
Bellevue, WA

Apply Now

Job Details

Full-time

Qualifications

Medical writing
Content creation for technical audiences
English
Clinical data report preparation
Technical writing within technology
Scientific reports

Full Job Description

Global Regulatory Writing & Consulting (GLOBAL) specializes in providing expert consulting, regulatory submission support, and strategic writing services for the pharmaceutical and medical device industries. The company focuses on delivering tailored, high-quality solutions to help clients navigate complex regulatory pathways with confidence. GLOBAL offers a wide range of core services, including regulatory strategy, clinical trial and marketing application authoring, lifecycle management, and clinical and non-clinical medical writing. With deep expertise and a dedicated team, GLOBAL combines the resources of a leading contract research organization (CRO) with the personal attention and flexibility of a smaller, agile partner.

Role Description

This is a full-time remote role for a Medical Writing Manager. The Medical Writing Manager will lead end-to-end project management for regulatory writing deliverables across EU MDR and/or FDA premarket pathways, including:

Clinical Evaluation Reports (CERs)

PMCF documentation and plans/reports

SSCPs

EU MDR Technical Documentation (Annex II/III)

FDA premarket submissions (510(k), De Novo, PMA), as applicable

Serve as the primary client interface, managing communications, expectations, timelines, and issue resolution across ongoing engagements.

Interpret and operationalize regulatory requirements into executable project plans and writing strategies, including:

EU MDR, MEDDEV 2.7/1 Rev 4, MDCG guidance

FDA device regulations and premarket expectations (as applicable)

Lead development of regulatory strategies and submission approaches for both EU and/or US market entry.

Direct, delegate, and oversee the work of Medical Writers, including workload allocation, timeline management, and detailed quality review of deliverables.

Ensure scientific rigor, internal consistency, and regulatory compliance across all documentation.

Manage multiple concurrent projects and client portfolios in a deadline-driven consulting environment.

Proactively identify project risks (timeline, scope, quality, regulatory) and implement mitigation strategies.

Support regulatory authority and Notified Body interactions, including:

Preparation of deficiency responses

Audit readiness activities

Health Authority question responses (FDA and/or EU)

Drive continuous improvement of templates, processes, and workflows to enhance efficiency, scalability, and quality.

Contribute to business development activities, including marketing, proposal development, scoping, and client onboarding.

Qualifications

Education

Master's degree or higher in a scientific, medical, or engineering discipline preferred.

Experience

5+ years of experience in medical device regulatory writing, with demonstrated EU MDR expertise.

Required: Demonstrated experience authoring Clinical Evaluation Reports (CERs).

Additionally required (at least one of the following):

Experience supporting FDA premarket submissions (510(k), De Novo, and/or PMA), including authoring and/or strategy

OR

Experience authoring and/or leading EU MDR Technical Documentation (Annex II/III) and broader MDR submission strategy

Strong working knowledge of:

EU MDR, MEDDEV 2.7/1 Rev 4, and applicable MDCG guidance

FDA device regulatory framework

Experience managing complex projects and/or leading teams in a consulting or regulatory environment.

Demonstrated experience conducting comprehensive literature reviews, data appraisal, and state-of-the-art analyses.

Experience interacting with Notified Bodies and/or FDA and preparing responses to regulatory questions strongly preferred.

Core Competencies
Advanced project and budget management skills.

Strong leadership experience, including mentoring, training, and performance oversight of junior staff.

Exceptional attention to detail with extensive experience performing high-level quality reviews.

Proficiency in literature management tools (e.g., EndNote or equivalent).

Strong analytical skills, including interpretation of clinical and scientific data.

Advanced proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Teams, SharePoint).

Excellent written and verbal communication skills.

Other
- Fluency in English required.
Job Description
Company Description

Global Regulatory Writing & Consulting (GLOBAL) specializes in providing expert consulting, regulatory submission support, and strategic writing services for the pharmaceutical and medical device industries. The company focuses on delivering tailored, high-quality solutions to help clients navigate complex regulatory pathways with confidence. GLOBAL offers a wide range of core services, including regulatory strategy, clinical trial and marketing application authoring, lifecycle management, and clinical and non-clinical medical writing. With deep expertise and a dedicated team, GLOBAL combines the resources of a leading contract research organization (CRO) with the personal attention and flexibility of a smaller, agile partner.

Role Description

This is a full-time remote role for a Medical Writing Manager. The Medical Writing Manager will lead end-to-end project management for regulatory writing deliverables across EU MDR and/or FDA premarket pathways, including:

Clinical Evaluation Reports (CERs)

PMCF documentation and plans/reports

SSCPs

EU MDR Technical Documentation (Annex II/III)

FDA premarket submissions (510(k), De Novo, PMA), as applicable

Serve as the primary client interface, managing communications, expectations, timelines, and issue resolution across ongoing engagements.

Interpret and operationalize regulatory requirements into executable project plans and writing strategies, including:

EU MDR, MEDDEV 2.7/1 Rev 4, MDCG guidance

FDA device regulations and premarket expectations (as applicable)

Lead development of regulatory strategies and submission approaches for both EU and/or US market entry.

Direct, delegate, and oversee the work of Medical Writers, including workload allocation, timeline management, and detailed quality review of deliverables.

Ensure scientific rigor, internal consistency, and regulatory compliance across all documentation.

Manage multiple concurrent projects and client portfolios in a deadline-driven consulting environment.

Proactively identify project risks (timeline, scope, quality, regulatory) and implement mitigation strategies.

Support regulatory authority and Notified Body interactions, including:

Preparation of deficiency responses

Audit readiness activities

Health Authority question responses (FDA and/or EU)

Drive continuous improvement of templates, processes, and workflows to enhance efficiency, scalability, and quality.

Contribute to business development activities, including marketing, proposal development, scoping, and client onboarding.

Qualifications

Education

Master's degree or higher in a scientific, medical, or engineering discipline preferred.

Experience

5+ years of experience in medical device regulatory writing, with demonstrated EU MDR expertise.

Required: Demonstrated experience authoring Clinical Evaluation Reports (CERs).

Additionally required (at least one of the following):

Experience supporting FDA premarket submissions (510(k), De Novo, and/or PMA), including authoring and/or strategy

OR

Experience authoring and/or leading EU MDR Technical Documentation (Annex II/III) and broader MDR submission strategy

Strong working knowledge of:

EU MDR, MEDDEV 2.7/1 Rev 4, and applicable MDCG guidance

FDA device regulatory framework

Experience managing complex projects and/or leading teams in a consulting or regulatory environment.

Demonstrated experience conducting comprehensive literature reviews, data appraisal, and state-of-the-art analyses.

Experience interacting with Notified Bodies and/or FDA and preparing responses to regulatory questions strongly preferred.

Core Competencies
Advanced project and budget management skills.

Strong leadership experience, including mentoring, training, and performance oversight of junior staff.

Exceptional attention to detail with extensive experience performing high-level quality reviews.

Proficiency in literature management tools (e.g., EndNote or equivalent).

Strong analytical skills, including interpretation of clinical and scientific data.

Advanced proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Teams, SharePoint).

Excellent written and verbal communication skills.

Other
- Fluency in English required.
ABOUT THE COMPANY
- Government Careers
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Whether you’re starting your career or seeking new opportunities, these roles provide pathways for growth, security, and service.

Explore positions across a wide range of fields and take the first step toward a rewarding future in public service.

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Refine Your Search

regulatory affairs manager jobs in bellevue wa

Medical Device Regulatory Affairs & Clinical Evaluation Manager

Regulatory Response Case Manager, Governance and External Affairs

Director of Environmental Affairs

Delivery Lead, Stratgic Perfom

Sr. Complaint Analyst

Economic Development Manager

Sr. Complaint Analyst

Compliance Specialist, Product Compliance, AWS Global Trade & Product Compliance

Sr. Compliance Specialist, AWS Global Trade & Product Compliance

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