Jobs
>
Bothell

    Senior Regulatory Affairs Specialist - Bothell, United States - Verathon

    Verathon
    Verathon Bothell, United States

    1 week ago

    Default job background
    Description
    Senior Regulatory Affairs Specialist

    Location

    US-Bothell


    ID
    Category

    Quality Assurance/Regulatory Affairs

    Position Type

    Full-Time

    Work Model

    Hybrid

    Company Overview

    Verathon


    is a global medical device company focused on supporting customers by being their trusted partner, delivering high-quality products that endure over time and ensure clinical and economic utility.

    Two areas where Verathon has significantly impacted patient care, and become the market leader in each, are bladder volume measurement and airway management.

    The company's BladderScan portable ultrasound and GlideScope video laryngoscopy & bronchoscopy systems effectively address unmet needs for healthcare providers and meaningfully raise the standard of care for patients.

    Verathon, a subsidiary of Roper Technologies, is headquartered in Bothell, Washington, USA and has international subsidiaries in Canada, Europe and Asia Pacific.

    For more information, please visit
    Overview


    Verathon is looking for a Senior Regulatory Affairs Specialist to become the newest member of our QA/RA Team located in Bothell, WA.

    This is a site-based role.

    The Senior Regulatory Affairs Specialist is an individual contributor responsible for creating and submitting 510(k) applications, including coordinating any pre-submissions and requests for additional information to obtain clearance.

    Responsibilities


    Serve as a core team member in cross-functional new product development teams, leading the development and execution of regulatory strategies in alignment with business objectives and regulatory requirements.

    Plan, develop, prepare, and obtain timely approval for product submissions, with focus on US FDA 510(k) applications.
    Ensure compliance with all applicable regulatory requirements governing Verathon, Inc. products, with focus on US FDA.
    Train and mentor junior regulatory affairs team members.
    Provide regulatory advice for product design, manufacturing, enhancements, marketing advertising and promotional materials.

    Ensure compliance with internal procedures, applicable regulations, guidelines, local country registration requirements, with emphasis on FDA's Quality System Regulation for Design Control and labeling requirements.

    Provide clear and consistent regulatory guidance to facilitate timely delivery of leading-edge products and services to Verathon's customers.
    Qualifications


    Capable, confident individual contributor with8+ years of related experience with a Bachelor's degree, 6+ years of experience with a Master's degree; or 3+ years of experience with a PhD.

    Working knowledge of all FDA submission requirements, including 510(k), Q-Submission, and associated guidance documents.
    Demonstrated experience in submitting and obtaining clearance with US FDA.
    Knowledgeable and skilled core team regulatory affairs representative to ensure regulatory requirements are fulfilled and adequate.

    Subject Matter Expert in design dossiers and design history file content to ensure design documentation is adequate to support regulatory submissions.

    Possess excellent situational influencing skills with ability to work effectively in cross-functional teams with R&D, quality, marketing, manufacturing, clinical, and other project team functions.

    Must have exceptional writing, verbal, and people skills with internal and external stakeholders.
    Maintain positive, collaborative relationships with all regulatory agencies.
    Salary range - $112,964 - $154,901 (Compensation will vary based on skills, experience and location.

    If this position is filled outside the Seattle WA metro area, this salary range will vary depending on the specific hiring location.)


    Full-time non-sales employees are eligible for Verathon's annual bonus plan based on company and individual performance.

    Verathon provides a competitive benefits package including medical, dental, vision, basic life insurance, paid holidays, paid time off and a 401(k) matching plan.

    For more information, please visit our complete Benefits Summary at

    EEO
    Verathon is an equal opportunity employer and strongly supports diversity in the workplace. We believe that diverse ideas, opinions and perspectives will build a strong foundation for success.

    In order to provide equal employment and advancement opportunities to all individuals, employment decisions at Verathon will be based on merit, qualifications, and abilities.

    Verathon does not discriminate in employment opportunities or practices on the basis of race, color, religion, sexual orientation, gender identity, national origin, age, disability, or any other characteristic protected by law.

    #J-18808-Ljbffr
  • Verathon

    Senior Regulatory Affairs Specialist

    2 weeks ago

    Verathon Bothell, United States Full time

    Overview · Verathon is looking for a Senior Regulatory Affairs Specialist to become the newest member of our QA/RA Team located in Bothell, WA. This is a site-based role. · The Senior Regulatory Affairs Specialist is an individual contributor responsible for creating and submit ...

  • Verathon

    Senior Regulatory Affairs Specialist

    1 week ago

    Verathon Bothell, United States

    Senior Regulatory Affairs Specialist Location US-Bothell ID Category Quality Assurance/Regulatory Affairs Position Type Full-Time Work Model Hybrid Company Overview Verathon is a global medical device company focused on supporting customers by being their trusted partner, deliver ...

  • Verathon

    Senior Regulatory Affairs Specialist

    1 week ago

    Verathon Bothell, United States

    · Senior Regulatory Affairs Specialist · Location · US-Bothell · ID · Category · Quality Assurance/Regulatory Affairs · Position Type · Full-Time · Work Model · Hybrid · Company Overview · Verathon is a global medical device company focused on supporting customers by ...

  • Philips

    Senior Regulatory Affairs Specialist

    15 hours ago

    Philips Bothell, United States

    Job Title · Senior Regulatory Affairs Specialist · Job Description · Looking at the challenges the world is facing today Philips' purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you'll be working towards creating a bet ...

  • Verathon

    Senior Regulatory Affairs Specialist

    3 weeks ago

    Verathon Bothell, United States

    Verathon, Inc. · Senior Regulatory Affairs Specialist · Bothell , · Washington · Apply Now · Senior Regulatory Affairs Specialist - VerathonVerathon is seeking a highly experienced and motivated Senior Regulatory Affairs Specialist to join our dynamic QA/RA Team in Bothell, ...

  • Bruker

    Sr. Regulatory Affairs Specialist

    3 weeks ago

    Bruker Bothell, United States

    Sr. Regulatory Affairs SpecialistJob LocationsUS-WA-Bothell | US-WA-SeattleID # of Openings1Job FunctionQuality & RegulatoryOverviewThe Senior, Regulatory Affairs Specialist is responsible for acting as the regulatory representative on product development teams aiming to achieve ...

  • Bruker

    Sr. Regulatory Affairs Specialist

    3 weeks ago

    Bruker Bothell, United States

    Sr. Regulatory Affairs Specialist · Job Locations · US-WA-Bothell | US-WA-Seattle · ID · # of Openings · 1 · Job Function · Quality & Regulatory · Overview · The Senior, Regulatory Affairs Specialist is responsible for acting as the regulatory representative on product d ...

  • Philips International

    Senior Regulatory Affairs Specialist

    3 weeks ago

    Philips International Bothell, United States

    Senior Regulatory Affairs Specialist page is loaded Senior Regulatory Affairs Specialist Apply locations Bothell Colorado Springs Plymouth San Diego Nashville time type Full time posted on Posted 2 Days Ago job requisition id Job Title Senior Regulatory Affairs Specialist Job Des ...

  • MicroSurgical Technology

    Sr. Regulatory Affairs Specialist

    1 week ago

    MicroSurgical Technology Redmond, United States

    Company Overview · MicroSurgical Technology (MST) is a highly profitable ophthalmic surgical solutions company headquartered in Redmond, Washington. MST is part of Halma PLC, a UK-based conglomerate with over $2.3B in annual sales. · Our products are surgeon-designed and meticu ...

  • MicroSurgical Technology

    Sr. Regulatory Affairs Specialist

    3 weeks ago

    MicroSurgical Technology Redmond, United States

    Company Overview · MicroSurgical Technology (MST) is a highly profitable ophthalmic surgical solutions company headquartered in Redmond, Washington. MST is part of Halma PLC, a UK-based conglomerate with over $2.3B in annual sales. · Our products are surgeon-designed and meticu ...

  • Bruker

    Sr. Regulatory Affairs Specialist

    6 days ago

    Bruker Seattle, United States

    Overview · The Senior, Regulatory Affairs Specialist is responsible for acting as the regulatory representative on product development teams aiming to achieve and maintain regulatory compliance for NanoString's products, with a particular focus on instrument/software development ...

  • Bruker

    Sr. Regulatory Affairs Specialist

    1 week ago

    Bruker Seattle, United States

    · Sr. Regulatory Affairs Specialist · Job Locations · US-WA-Seattle | US-WA-Seattle · ID · # of Openings · 1 · Job Function · Quality & Regulatory · Overview · The Senior, Regulatory Affairs Specialist is responsible for acting as the regulatory representative on produc ...

  • Bruker Nano Inc

    Sr. Regulatory Affairs Specialist

    1 week ago

    Bruker Nano Inc Seattle, United States

    Sr. Regulatory Affairs Specialist Job Locations US-WA-Bothell | US-WA-Seattle ID · of Openings · 1 Job Function Quality & Regulatory Overview The Senior, Regulatory Affairs Specialist is responsible for acting as the regulatory representative on product development teams aiming ...

  • Hobson Associates

    Senior Regulatory Affairs Specialist

    2 weeks ago

    Hobson Associates Seattle, United States

    Job Title: Senior Regulatory Affairs SpecialistLocation: Greater Seattle Area (Hybrid Role, Three Days In-Office)Our client is looking for a Senior Regulatory Affairs Specialist to become the newest member of our QA/RA Team located in the Seattle Area.The Senior Regulatory Affair ...

  • Bruker

    Sr. Regulatory Affairs Specialist

    6 days ago

    Bruker Seattle, United States

    Sr. Regulatory Affairs Specialist · Job Locations · US-WA-Seattle | US-WA-Seattle · ID · # of Openings · 1 · Job Function · Quality & Regulatory · Overview · The Senior, Regulatory Affairs Specialist is responsible for acting as the regulatory representative on product d ...

  • Bio-Rad Laboratories

    Regulatory Affairs Specialist III

    3 days ago

    Bio-Rad Laboratories Seattle, United States

    As a Bio-Rad · Regulatory Affairs Specialist III · you will support Bio-Rad's commitment to quality and compliance by coordinating the internal and external audits as a Regulatory Specialist. As part of Bio-Rad's Seattle Opeartions RA team, you'll apply your strong leadership s ...

  • Bio-Rad Laboratories

    Regulatory Affairs Specialist III

    2 weeks ago

    Bio-Rad Laboratories Seattle, United States

    As a Regulatory Affairs Specialist, you will support Bio-Rad's commitment to quality and compliance by coordinating the internal and external audits as a Regulatory Specialist. As part of Bio-Rad's Seattle Operations RA team, you'll apply your strong leadership skills and knowled ...

  • AbD Serotec

    Regulatory Affairs Specialist III

    1 week ago

    AbD Serotec Seattle, United States

    As a Bio-Rad Regulatory Affairs Specialist III you will supportBio-Rad's commitment to quality and compliance by coordinating the internal and external audits as a Regulatory Specialist. As part of Bio-Rad's Seattle Opeartions RA team, you`ll apply your strong leadership skills a ...

  • Bio-Rad Laboratories

    Regulatory Affairs Specialist III

    1 week ago

    Bio-Rad Laboratories Seattle, United States

    As a Bio-Rad Regulatory Affairs Specialist III you will support Bio-Rad's commitment to quality and compliance by coordinating the internal and external audits as a Regulatory Specialist. As part of Bio-Rad's Seattle Opeartions RA team, you'll apply your strong leadership skills ...

  • Fluke Biomedical Corporation

    Senior Regulatory Affairs Specialist

    3 days ago

    Fluke Biomedical Corporation Everett, United States

    Position Summary · The Senior Regulatory Affairs Specialist (Sr, RA Specialist) is responsible for developing regulatory strategies, preparing Local submissions and supporting international submissions to obtain and maintain approval/certification for drug/device products and the ...