Jobs
>
Seattle

    Senior Regulatory Affairs Specialist - Seattle, United States - Hobson Associates

    Hobson Associates
    Hobson Associates Seattle, United States

    2 weeks ago

    Default job background
    Description

    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 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.


    Principal 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 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 customers.


    Knowledge, Skills, and Abilities:


    Capable, confident individual contributor with 8+ years of experience with a Bachelors degree, 6+ years of experience with a Masters 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.


    About Hobson Associates' Client:


    Our client 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.

    The device family revolves around bladder volume measurement and airway management.#J-18808-Ljbffr
  • Providence

    Regulatory Affairs Specialist

    3 days ago

    Providence Seattle, United States Full time

    Regulatory Affairs Specialist - Clinical Research - Swedish Cherry Hill · Schedule: (Full-time; Day shift) 8:00 AM to 5:00 PM PST (Mondays to Fridays) · Prepares, facilitates, coordinates, and submits documentation required by federal, state and local regulations and institutio ...

  • Providence Service

    Regulatory Affairs Specialist

    1 day ago

    Providence Service Seattle, United States

    Description · Regulatory Affairs Specialist - Clinical Research - Swedish Cherry Hill · Schedule: (Full-time; Day shift) 8:00 AM to 5:00 PM PST (Mondays to Fridays) · Prepares, facilitates, coordinates, and submits documentation required by federal, state and local regulations an ...

  • Providence Health & Service

    Regulatory Affairs Specialist

    1 day ago

    Providence Health & Service Seattle, United States

    Job DescriptionRegulatory Affairs Specialist - Clinical Research - Swedish Cherry HillSchedule: (Full-time; Day shift) 8:00 AM to 5:00 PM PST (Mondays to Fridays)Prepares, facilitates, coordinates, and submits documentation required by federal, state and local regulations and ins ...

  • Providence Swedish Medical Center

    Regulatory Affairs Specialist

    9 hours ago

    Providence Swedish Medical Center Seattle, United States

    Regulatory Affairs Specialist - Clinical Research - Swedish Cherry Hill · Schedule: (Full-time; Day shift) · 8:00 AM to 5:00 PM PST (Mondays to Fridays) · Prepares, facilitates, coordinates, and submits documentation required by federal, state and local regulations and instituti ...

  • Swedish Medical Center

    Regulatory Affairs Specialist

    2 days ago

    Swedish Medical Center Seattle, United States

    Description · Regulatory Affairs Specialist - Clinical Research - Swedish Cherry Hill · Schedule: (Full-time; Day shift) 8:00 AM to 5:00 PM PST (Mondays to Fridays) · Prepares, facilitates, coordinates, and submits documentation required by federal, state and local regulations an ...

  • Swedish Health Services

    Regulatory Affairs Specialist

    9 hours ago

    Swedish Health Services Seattle, United States

    Regulatory Affairs Specialist - Clinical Research - Swedish Cherry Hill · Schedule: (Full-time; Day shift) · 8:00 AM to 5:00 PM PST (Mondays to Fridays) · Prepares, facilitates, coordinates, and submits documentation required by federal, state and local regulations and instituti ...

  • Bruker

    Sr. Regulatory Affairs Specialist

    1 week 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 product d ...

  • Bruker

    Sr. Regulatory Affairs Specialist

    2 weeks 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 ...

  • 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 ...

  • 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 s ...

  • 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

    2 weeks 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 ...

  • U.S. Army Corps Of Engineers

    public affairs specialist

    2 weeks ago

    U.S. Army Corps Of Engineers Seattle, United States Full time

    Reviews and analyzes district programs and policies for their relationship to public opinion. · Advises key staff elements of public affairs implications of events, programs and activities and of developing trends on controversial issues raised by the news media or public. · Eval ...

  • Bruker Nano Inc

    Sr. Regulatory Affairs Specialist

    3 weeks ago

    Bruker Nano Inc Seattle, United States

    Bruker Nano Inc · Sr. Regulatory Affairs Specialist · Seattle , · Washington · Apply Now · Sr. Regulatory Affairs SpecialistJob LocationsUS-WA-Bothell | US-WA-SeattleID · of Openings · 1Job FunctionQuality & RegulatoryOverviewThe Senior, Regulatory Affairs Specialist is re ...

  • Verathon

    Senior Regulatory Affairs Specialist

    3 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 ...

  • MicroSurgical Technology

    Sr. Regulatory Affairs Specialist

    2 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 ...

  • 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 ...

  • 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 ...