Government Affairs Representative jobs in New Haven, CT

Government Affairs Representative supports the implementation of strategic plans and engagement objectives to develop and maintain productive relations with all levels of government authorities to achieve business goals. Liaises with government entities (federal, state, provincial, or local) that regulate or influence business activities. Being a Government Affairs Representative collaborates with industry groups and organizations with complementary objectives to achieve objectives. Monitors and analyses proposed legislation, emerging issues, and trends and prepare reports and informational documents to inform and support business leaders. Additionally, Government Affairs Representative requires a bachelor's degree in public policy, public administration, business or equivalent. Typically reports to a manager. The Government Affairs Representative work is generally independent and collaborative in nature. Contributes to moderately complex aspects of a project. To be a Government Affairs Representative typically requires 4 -7 years of related experience. (Copyright 2024 Salary.com)

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Sr. Regulatory Affairs Specialist
  • Hyperfine
  • Guilford, CT FULL_TIME
  • Company Profile

    Hyperfine (NASDAQ: HYPR) is the groundbreaking MedTech company that created Swoop, the world’s first FDA-cleared portable magnetic resonance imaging (MRI) system capable of providing neuroimaging at the point of care. Our mission is to transform patient care by creating access to life-saving diagnostics and actionable data at the point of care.

    Today, eighty percent of the world’s population lacks access to MRI. Hyperfine is on a mission to address the limitations of current imaging technologies and make MR imaging accessible anytime and anywhere.

    Do you have a background in magnetic resonance imaging, deep learning, electrical engineering, physics, or related fields? What about health equipment sales, business development, or marketing? Hyperfine lives and works on the cutting edge of medical imaging accessibility. If you enjoy a challenge as much as you value a committed workplace, we could be the next step in your rising career.

     

    Job Title: Senior Regulatory Affairs Specialist

    Location:  Guilford, CT

     

    SUMMARY:

    The Senior Regulatory Affairs Specialist supports product development as a core team member and is responsible for regulatory submissions and registrations. The Senior Affairs Regulatory Specialist ensures internal and external compliance with stated practices and procedures and supports regulatory and agency inspections and/or audits as necessary. The Senior Regulatory Affairs Specialist provides regulatory guidance to cross-functional teams; develops global regulatory strategies; advises on labeling and marketing materials for regulatory compliance; and evaluates product changes for impact on regulatory filings worldwide.

     

    RESPONSIBILITIES:

    • Evaluate the regulatory environment and provide internal advice throughout the product life cycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance
    • Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions
    • Determine requirements and options for regulatory submissions, approval pathways, and compliance activities
    • Develop global regulatory strategies and update based on changes in the regulatory landscape
    • Act as core team member on development teams to provide input on design controls and regulatory deliverables
    • Ensure regulatory strategy outputs are properly communicated to development teams and the business
    • Support product development by guiding teams on regulatory issues, including review of scientific/engineering material (protocols/reports), interpretation of standards, regulations, and guidance documents
    • Communicate and interact with regulatory authorities before and during the development and review of a regulatory submission
    • Author and lead the preparation of all necessary regulatory submissions (as assigned), in compliance with applicable regulatory requirements
    • Monitor the progress of the regulatory agency review process via appropriate communication with the agency
    • Evaluate proposed product changes for regulatory filing solutions and propose plans for changes that do not require submissions (as applicable)
    • Review and approve engineering change orders for product modifications
    • Help to train stakeholders on current and new regulatory requirements to ensure company-wide compliance
    • Provide regulatory input, guidance and review for proposed product claims and device labeling
    • Support QMS audits to meet applicable regulatory requirements
    • Influence departmental processes by implementing/updating SOPs
    • Support in recruiting, hiring, and training regulatory personnel
    • Other duties as assigned

     

    KNOWLEDGE AND SKILL:

    • Thorough working knowledge of Quality System standards and regulations including 21 CFR 820, ISO 13485, MDSAP, EU MDD/MDR
    • Thorough working knowledge of risk management and other standards including ISO 14971, IEC 60601, and IEC 62304
    • Experience interpreting FDA and international guidelines and regulations
    • Extensive experience in international regulatory filings
    • Track record of navigating swiftly and efficiently through the regulatory process as part of a team ensuring project and company success
    • Experience with medical device labeling requirements
    • Detail oriented, hands-on, proactive problem solver
    • Excellent written and oral communication skills including the ability to interact with all levels of the company
    • Excellent ability to read, analyze and interpret technical documents, professional journals, technical procedures, and regulations
    • Experience supporting audits
    • Ability to work with minimal supervision

     

    EDUCATION/EXPERIENCE REQUIRED:

    • Bachelor’s degree or higher degree
    • Minimum of 7 years’ experience in the medical device industry
    • Minimum of 3 years’ experience in a Regulatory Affairs Role

    Applicants must be authorized to work for ANY employer in the U.S.  We are unable to sponsor or take over sponsorship of any employment visa at this time.

  • 18 Days Ago

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Regulatory Affairs Specialist
  • Integrated Resources INC
  • North Haven, CT FULL_TIME
  • Company DescriptionIntegrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent ...
  • 14 Days Ago

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Director, Regulatory Affairs
  • Unite Us
  • New Haven, CT FULL_TIME
  • About the Role: The Director of Regulatory Affairs will work on the team of the Senior Vice President of Regulatory and Government Affairs to assess regulatory changes at the federal and state levels,...
  • 1 Month Ago

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HSPD-12: Government Badging & Credentialing Specialist (West Haven)
  • Citizant
  • West Haven, CT FULL_TIME
  • Company DescriptionCitizant is a leading provider of professional IT services to the U.S. government. We seek to address some of our country's most pressing challenges in the areas of Agile applicatio...
  • 4 Days Ago

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Temporary Paralegal/Courtroom-State Government Employment- Paid
  • New Haven Judicial District - Superior Court
  • New Haven, CT TEMPORARY
  • The State of Connecticut Judicial Branch, Superior Court Operations Division, New Haven Judicial District Superior Court is seeking paralegals to assist staff with courtroom activities in the Superior...
  • 5 Days Ago

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Covid System Administrator - US Department of Veteran Affairs
  • TLN Worldwide Enterprises Inc
  • West Haven, CT FULL_TIME
  • DescriptionPosition Title: COVID Systems AdministratorAs an onsite Systems Administrator on our project, you will be supporting the Department of Veterans' Affairs. You'll analyze problem areas and op...
  • 3 Days Ago

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0 Government Affairs Representative jobs found in New Haven, CT area

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Hospice Marketing and Sales Liaison
  • Affinity Hospice Management LLC
  • Hamden, CT
  • Affinity Hospice Management LLC - Job Title/Position: Community Liaison Reports To: Administrator Job Description Summar...
  • 3/28/2024 12:00:00 AM

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Grants Manager - BOE (Special Funds)
  • NHPS
  • New Haven, CT
  • JOB DESCRIPTION: GENERAL WORKER - CAFETERIA UNION AFFILIATION: Local 217 (Hotel & Restaurant Employees & Bartenders Unio...
  • 3/28/2024 12:00:00 AM

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Sr. Associate Provost, Research Administration
  • Yale University
  • New Haven, CT
  • Essential Duties 1. Overall responsibility for managing the services needed to support externally funded faculty researc...
  • 3/28/2024 12:00:00 AM

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Lead Transportation Security Officer
  • Transportation Security Administration
  • New Haven, CT
  • Summary Securing Travel, Protecting People - At the Transportation Security Administration, you will serve in a high-sta...
  • 3/27/2024 12:00:00 AM

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Surgical Service Representative
  • Steris plc.
  • New Haven, CT
  • Job Title: Surgical Service Representative Description: At STERIS, we help our Customers create a healthier and safer wo...
  • 3/27/2024 12:00:00 AM

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Estimating Manager - Construction
  • Metro Environmental Services
  • Holbrook, NY
  • Job Description Job Description Trusted since 2002, Metro Environmental Services (MES) is an industry-leading environmen...
  • 3/25/2024 12:00:00 AM

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Estimating Manager - Construction
  • Metro Environmental Services
  • Lake Ronkonkoma, NY
  • Job Description Job Description Trusted since 2002, Metro Environmental Services (MES) is an industry-leading environmen...
  • 3/25/2024 12:00:00 AM

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SENIOR MANAGER, GRANTS AND CONTRACTS
  • New Haven Ecology Project Inc
  • New Haven, CT
  • Job Description Job Description Common Ground is Seeking a Senior Manager, Grants and Contracts For Immediate Hire - Ful...
  • 3/24/2024 12:00:00 AM

New Haven is a coastal city in the U.S. state of Connecticut. It is located on New Haven Harbor on the northern shore of Long Island Sound in New Haven County, Connecticut, and is part of the New York metropolitan area. With a population of 129,779 as determined by the 2010 United States Census, it is the second-largest city in Connecticut after Bridgeport. New Haven is the principal municipality of Greater New Haven, which had a total population of 862,477 in 2010. New Haven was the first planned city in America. A year after its founding by English Puritans in 1638, eight streets were laid o...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Government Affairs Representative jobs
$96,378 to $132,056
New Haven, Connecticut area prices
were up 1.7% from a year ago

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February 02, 2020
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Government Affairs Representative in Sarasota, FL
Working with the Vice President of External Affairs & Corporate Communications, the Representative will develop and execute an annual outreach and engagement program to achieve stronger statewide recognition with business, philanthropic, and advocacy groups and support the NYISO’s position as a leader in the energy space.
February 20, 2020