Jobs
>
Lalande-de-Pomerol

    Senior Regulatory Affairs Specialist - Miami, United States - DemeTech

    DemeTech
    DemeTech Miami, United States

    2 weeks ago

    Default job background
    Description

    DemeTECH is seeking a highly motivated and detail-oriented Sr. Regulatory Affairs Specialist to join our team. The ideal candidate will play a pivotal role in ensuring our products meet all regulatory standards and achieve timely market access. This role involves collaboration across various departments, providing regulatory guidance, and managing submissions to regulatory bodies.

    The following information provides an overview of the skills, qualities, and qualifications needed for this role.

    Responsibilities:

    • Prepare and submit regulatory documents required for the approval and registration of new and existing products in various markets.
    • Stay informed on global regulatory requirements and changes, especially those related to medical devices and surgical sutures, and assess their impact on company products.
    • Coordinate with R&D, quality assurance, and other departments to compile necessary documentation for regulatory submissions.
    • Advise on regulatory requirements during product development stages.
    • Monitor compliance with post-market surveillance and reporting obligations.
    • Assist in developing and implementing regulatory strategies to support market entry and expansion.
    • Provide regulatory support and guidance to internal teams and external partners.

    Education: Bachelor's degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred.

    Communication skills: Good technical capabilities, communication skills, teamwork abilities and initiative

    Technical Proficiencies: Regulatory Affairs Certification (US or EU) preferred. Proven ability to work well as part of a team & on own with minimum supervision. Working knowledge of FDA and other regulatory authorities with experience supporting compliance.

    Experience: 6-8 years of experience in Regulatory Affairs, including preparation of submissions to the FDA/EU. A minimum of 6 years of experience in medical device, drugs, biologics, and/or combination products, preferred

  • National Conference of State Legislatures

    Specialist, State Legislative Affairs

    1 week ago

    National Conference of State Legislatures Miami, United States

    Maine Office of Policy and Legal Analysis · Washington State House of Representatives · South Dakota Legislative Research Council · South Dakota Legislative Research Council · This position is located on-site at the APTA headquarters in Alexandria, VA Summary This position he ...

  • Danaher Corporation

    Staff Clinical Compliance Specialist

    6 days ago

    Danaher Corporation Miami, United States

    At first glance, you'll see that for more than 80 years we've been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We're building a culture that celebrates backg ...

  • Dudek

    UAS Pilot

    1 week ago

    Dudek Miami, United States

    **Dudek** · **UAS Pilot - On-Call** · **Mapping/Surveying - Miami, Palm Beach, remote work, FL - Seasonal** · Dudek is currently seeking an As-needed UAS Pilot to join our team. Unmanned Aircraft Systems Operators are remote pilots of unmanned observation aircrafts, aka UAVs ( ...

  • University of Miami Health System

    Cath Lab Director in Miami, Florida

    3 weeks ago

    University of Miami Health System Miami, United States

    The University of Miami Health System, Miller School of Medicine is initiating a search for a Cath Lab Director, Associate Professor of Cardiovascular Medicine. · Essential Job Functions: · Oversee and manage the daily operations of the cardiac catheterization laboratory and inte ...

  • The University of Miami

    Cath Lab Director, Associate Professor of Cardiovascular Medicine

    1 week ago

    The University of Miami Miami, United States

    Current Employees: · If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet, please review ...

  • Verona Pharma

    Respiratory Sales Specialist, Miami, FL

    3 weeks ago

    Verona Pharma Miami, United States

    Respiratory Sales Specialist, Miami, FL (Miami, FL) · The Company: · Our mission is to improve the health and quality of life for the millions of people affected by chronic respiratory diseases. We do this principally through the development of our first-in-class molecule, ensi ...

  • City National Bank

    Relationship Manager Entertainment

    3 weeks ago

    City National Bank Miami, United States

    RELATIONSHIP MANAGER ENTERTAINMENT · WHAT IS THE OPPORTUNITY? · Develops and manages relationships with clients in the assigned business segment and/or geographic areas. Presents a variety of product solutions to client needs. Provides responsive, quality service. Approves transa ...

  • Verona Pharma plc

    Respiratory Sales Specialist, Miami, FL

    1 week ago

    Verona Pharma plc Miami, United States

    Respiratory Sales Specialist, Miami, FL (Miami, FL) · The Company: · Our mission is to improve the health and quality of life for the millions of people affected by chronic respiratory diseases. We do this principally through the development of our first-in-class molecule, ensi ...

  • Centers for Disease Control and Prevention

    Public Health Advisor Quarantine Program

    1 week ago

    Centers for Disease Control and Prevention Miami, United States

    Duties · As a Public Health Advisor (Quarantine Program) you will: · Serve as a recognized authority for and represent the Division of Global Migration and Quarantine (DGMQ) programs and activities at ports of entry and transit in the servicing jurisdiction. · Provide guidance, a ...

  • Verona Pharma

    Respiratory Sales Specialist, Miami, FL

    1 week ago

    Verona Pharma Miami, United States

    Respiratory Sales Specialist, Miami, FL (Miami, FL)The Company:Our mission is to improve the health and quality of life for the millions of people affected by chronic respiratory diseases. We do this principally through the development of our first-in-class molecule, ensifentrine ...

  • Mitsubishi Chemical Group

    Neurology Account Specialist

    1 week ago

    Mitsubishi Chemical Group Miami, United States

    Overview · Entrepreneurial Spirit, Rooted in Tradition . Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a U.S. subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC) in Japan, which touts a storied reputation more than 300 years in the making. Our parent company - one of Ja ...