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Regulatory Affairs Jobs in Bellevue, WA

Jobs

Regulatory Affairs Associate II InBios International Inc

Seattle, WA

$92,196–$125,000 / year

The ideal candidate has a strong understanding of U.S. and international regulatory requirements for diagnostic products, is experienced in preparing regulatory submissions and supporting cross-functional product development teams and has a thesis-based advanced degree in Life Sciences, Bioengineering, or a related discipline. This position supports the development, registration, commercialization, and lifecycle management of innovative in vitro diagnostic (IVD) products designed to address emerging infectious diseases and biothreats.

5 days ago

Manager, Regulatory Affairs (Aesthetic Medical Device) (Bothell, WA) Bausch Health Companies Inc

Bothell, WA

$115,000–$158,000 / year

Functional / Technical Knowledge: Product environmental and chemical compliance, preferably in the medical device industry; RoHS, REACH, SVHC, and product chemical regulations applicable to medical devices; F-gas Regulation and fluorinated substances used in medical devices or accessories; EU MDR technical documentation and product compliance annexes; supporting notified body audits or regulatory inspections; PLM and EH&S compliance data management systems; regulated quality system environments (ISO 13485 preferred); regulatory interpretation, technical documentation, and cross-functional collaboration. The EH&S Product Regulatory Compliance Manager ensures that the company's medical device and medicinal products comply with applicable global product-level environmental, health, safety, and chemical regulations, supporting global market access by integrating these requirements into product design, technical documentation, and lifecycle management.

7 days ago

Senior Regulatory Affairs Specialist (Hybrid) Stryker Corp

Redmond, WA

$95,800–$159,600 / year

However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. Evaluate proposed pre-clinical, clinical, and manufacturing changes for regulatory filing solutions and propose plans/strategies (if appropriate) for changes that do not require submissions.

16 days ago

Staff Regulatory Affairs Specialist (Hybrid) Stryker

Redmond, Washington

However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. In this role, you will help guide regulatory activities across product development, product changes, and lifecycle management while partnering with cross-functional teams to provide regulatory guidance and help ensure ongoing compliance and market availability.

17 days ago

Regulatory Affairs Specialist II Seattle Children's Hospital

Seattle, Washington

Together, we deliver superior patient care, advance new discoveries and treatments through pediatric research, and serve as the pediatric and adolescent, academic medical center for Washington, Alaska, Montana and Idaho – the largest region of any children’s hospital in the country. Guides and supports all clinical research team members in adhering to applicable federal regulations, state codes, institutional policies, and Institutional Review Board (IRB) oversight and review requirements when conducting research with human participants.

17 days ago

Regulatory Affairs Specialist II Seattle Children's Hospital Research and Foundation

Seattle, WA

$82,736–$124,104 / year

Together, we deliver superior patient care, advance new discoveries and treatments through pediatric research, and serve as the pediatric and adolescent, academic medical center for Washington, Alaska, Montana and Idaho - the largest region of any children's hospital in the country. Guides and supports all clinical research team members in adhering to applicable federal regulations, state codes, institutional policies, and Institutional Review Board (IRB) oversight and review requirements when conducting research with human participants.

17 days ago

Senior Manager, Regulatory Affairs Adaptive Biotechnologies Corp

Remote

$144,600–$217,000 / year

This role also owns the regulatory relationship with biopharma partners for companion diagnostic (CDx) and complementary diagnostic co-development programs, and maintains working knowledge of the US regulatory framework (FDA) to ensure a cohesive, globally aligned regulatory strategy. Base salary is thoughtfully considered upon offer and is determined through multiple evaluation checks throughout the interview process, including: a candidate's ability to meet minimum qualifications (skills/experience/education), a candidate's ability to thoughtfully address preferred qualifications, current market conditions, and internal pay equity.

21 days ago

Regulatory Affairs Associate Adaptive Biotechnologies Corp

Remote

$38.56–$57.88 / hour

Base salary is thoughtfully considered upon offer and is determined through multiple evaluation checks throughout the interview process, including: a candidate's ability to meet minimum qualifications (skills/experience/education), a candidate's ability to thoughtfully address preferred qualifications, current market conditions, and internal pay equity. The Regulatory Affairs Associate is responsible for assisting with assembling the regulatory submissions required to market new or modified in vitro diagnostic devices (IVD) in the US and in international markets.

21 days ago

Associate Director / Director, Regulatory Affairs CMC Immunome Inc

Bothell, WA

$177,399–$238,957 / year

This person will collaborate cross-functionally with teams including Technical Operations, Quality Assurance, Supply Chain Management, and Project Management to maintain alignment with regulatory CMC strategies and compliance requirements. We are advancing an innovative portfolio of therapeutics, supported by a leadership team with deep experience in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugates.

30+ days ago

Senior Manager, Clinical Regulatory Affairs Umoja Biopharma

Seattle, WA

$159,800–$197,400 / year

We are a diverse and growing team working in brand-new facilities in downtown Seattle, Washington and Louisville, Colorado, and we are looking for innovative thinkers who are excited by groundbreaking science and technology, and passionate about squaring up to the challenges inherent to cutting-edge drug development. Reporting to the Senior Director, Clinical Regulatory Affairs, this individual will contribute to the development, preparation, and maintenance of global regulatory submissions and health authority interactions in support of clinical development programs across the United States, European Union, and other global markets.

30+ days ago

Senior Manager, Clinical Regulatory Affairs Umoja BioPharma Inc

Seattle, WA

$159,800–$197,400 / year

Associate Director: Bachelor's degree in life sciences, pharmacy, regulatory affairs, or a related field required; advanced degree preferred with 8+ years of demonstrated experience supporting clinical-stage drug, biologic, cell therapy, oncology, immunology, or rare disease programs. We are a diverse and growing team working in brand-new facilities in downtown Seattle, Washington and Louisville, Colorado, and we are looking for innovative thinkers who are excited by groundbreaking science and technology, and passionate about squaring up to the challenges inherent to cutting-edge drug development.

30+ days ago

Quality Regulatory Affairs Coordinator JBL Resources

Redmond, WA

Quick Apply

JBL Resources is proud to have earned the reputation of being a premier provider of top talent professionals in the fields of engineering, human resources, logistics, operations, and supply chain management. Collaborating with internal stakeholders, such as PFA process leads, site execution owners, engineers, and technicians, to ensure seamless coordination and communication regarding field action deliverables.

8 days ago

Senior Regulatory Affairs Specialist Philips

Bothell, WA

$99,000–$157,000 / year

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. Lead global regulatory intelligence initiatives, contribute to regulatory and product registration strategies, and help implement global regulatory roadmaps based on the competitive landscape and marketing objectives.

30+ days ago

Associate Director / Director, Regulatory Affairs CMC Immunome

Bothell, Washington

30+ days ago

Manager, Regulatory Affairs Verathon, Inc.

Bothell, Washington

$116,581–$163,567 / year
Full time

The Manager, Regulatory Affairs leads the Regulatory Affairs function, managing the discipline through Regulatory Affairs Specialists and, as the team scales, subordinate supervisors responsible for obtaining and maintaining market authorizations across Verathon’s global device portfolio. Responsibilities: 510(k) Strategy and Submissions Own the end-to-end lifecycle of FDA 510(k) submissions across Verathon’s product lines, including predicate selection, substantial equivalence argumentation, and eSTAR preparation.

30+ days ago

Manager, Regulatory Affairs Verathon Inc

Bothell, WA

$116,581–$163,567 / year

The Manager, Regulatory Affairs leads the Regulatory Affairs function, managing the discipline through Regulatory Affairs Specialists and, as the team scales, subordinate supervisors responsible for obtaining and maintaining market authorizations across Verathon's global device portfolio. Translate Regulatory Affairs functional plans into operational processes, contribute to annual regulatory strategy and planning, and advise senior leadership on regulatory risk affecting business objectives.

30+ days ago

Project Manager – Regulatory Affairs Stark Pharma Solutions Inc

Redmond, WA

Quick Apply

We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success. The ideal candidate will have strong experience in global product registrations, regulatory submissions, dossier management, and LATAM regulatory activities, preferably with INVIMA.

30 days ago

Senior Director, Clinical Regulatory Affairs Umoja Biopharma

Seattle, WA

$249,900–$308,700 / year

We are a diverse and growing team working in brand-new facilities in downtown Seattle, Washington and Louisville, Colorado, and we are looking for innovative thinkers who are excited by groundbreaking science and technology, and passionate about squaring up to the challenges inherent to cutting-edge drug development. This role will develop and implement regulatory strategies leading to successful registration and life-cycle management of unique and technologically complex products serving patients with cancer and other unmet medical needs.

30+ days ago

Regulatory Affairs Project Manager Intellectt INC

Bothell, WA

Quick Apply

Bachelor's degree in Pharmacy, Life Sciences, Biotechnology, Regulatory Affairs, or related field. Strong project management, stakeholder management, and communication skills.

30 days ago

Vice President of Public Affairs & Government Affairs Zap Energy

Everett, Washington

$240,000–$310,000 / year

15+ years of experience in public affairs, communications, or external relations in a nascent or high-stakes industry — including at least one of the following relevant areas: commercial space, biotechnology, advanced energy, deep tech, semiconductors, or other sectors where public perception and policy environment had to be actively built, not inherited. You will help define the emerging category of the integrated nuclear company while ensuring Zap is a trusted voice in the national conversation around energy security, artificial intelligence infrastructure, advanced manufacturing, and technology leadership.

30+ days ago

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Regulatory Affairs Jobs in Bellevue, WA

Regulatory Affairs Associate II InBios International Inc

Manager, Regulatory Affairs (Aesthetic Medical Device) (Bothell, WA) Bausch Health Companies Inc

Senior Regulatory Affairs Specialist (Hybrid) Stryker Corp

Staff Regulatory Affairs Specialist (Hybrid) Stryker

Regulatory Affairs Specialist II Seattle Children's Hospital

Regulatory Affairs Specialist II Seattle Children's Hospital Research and Foundation

Senior Manager, Regulatory Affairs Adaptive Biotechnologies Corp

Regulatory Affairs Associate Adaptive Biotechnologies Corp

Associate Director / Director, Regulatory Affairs CMC Immunome Inc

Senior Manager, Clinical Regulatory Affairs Umoja Biopharma

Senior Manager, Clinical Regulatory Affairs Umoja BioPharma Inc

Quality Regulatory Affairs Coordinator JBL Resources

Senior Regulatory Affairs Specialist Philips

Associate Director / Director, Regulatory Affairs CMC Immunome

Manager, Regulatory Affairs Verathon, Inc.

Manager, Regulatory Affairs Verathon Inc

Project Manager – Regulatory Affairs Stark Pharma Solutions Inc

Senior Director, Clinical Regulatory Affairs Umoja Biopharma

Regulatory Affairs Project Manager Intellectt INC

Vice President of Public Affairs & Government Affairs Zap Energy

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