Regulatory Affairs Manager jobs in Rhode Island

Regulatory Affairs Manager manages regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Implements processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Manager utilizes established monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Manager investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Regulatory Affairs Manager typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)

S
Regulatory Affairs Manager
  • Sentec
  • Lincoln, RI FULL_TIME
  • Sentec is a market leader of non-invasive respiratory monitoring and intrapulmonary percussive
    ventilation (IPV) solutions who develops, manufactures, and markets patient-centric, cost-
    effective technologies and products. We aim to improve the lives of patients by advancing non-
    invasive patient care by empowering clinicians with clinically superior monitoring and therapeutic
    technologies.


    Regulatory Affairs Manager

    Key Tasks:

    • Product registrations and submissions in the US and Canada, working closely with the regulatory compliance
    team in Switzerland.
    • Review product, supplier, and manufacturing changes for compliance with applicable regulations and
    procedures.
    • Works cross-functionally to develop regulatory strategies, testing requirements, and other documentation.
    • Perform risk assessments and if required, report incidents to the authorities.
    • Stay abreast of regulatory requirement updates and standards.
    • Travel to Sentec facilities in North America and Switzerland as needed (anticipated 3-6 times annually)


    Our Offer:

    • Working environment in a growing company.
    • Directly influence on the quality of our products and make a difference for patients worldwide.
    • Opportunities for professional and personal growth.


    Your Profile:

    • Bachelor’s degree required.
    • 5 years’ experience in a Regulatory Affairs position within the medical device industry.
    • In depth knowledge of regulatory framework of medical devices for the FDA and Health Canada/MDSAP.
    • Analytical thinking and ability to compile scientific data and summarize results.
    • Fluent in English.


    To apply, send your resume to jobs.us@sentec.com

  • 9 Days Ago

S
Regulatory Affairs Specialist (Lincoln, RI)
  • Sentec
  • Lincoln, RI FULL_TIME
  • Sentec is a market leader of non-invasive respiratory monitoring solutions who develops, manufactures, and markets patient-centric, cost-effective technologies and products that provide clinicians wit...
  • 1 Day Ago

B
Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • Providence, RI FULL_TIME
  • Bausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurol...
  • 11 Days Ago

F
Product Regulatory Compliance Manager
  • Fujifilm
  • North, RI OTHER
  • Overview Who We Are FUJIFILM Electronic Materials, U.S.A., Inc., is a global leader in chemical solutions which enable the semiconductor industry and the digital universe. We have an exciting opportun...
  • 22 Days Ago

F
Product Regulatory Compliance Manager
  • FUJIFILM Holdings America Corporation
  • North, RI FULL_TIME
  • Product Regulatory Compliance Manager Job Locations US-RI-North Kingstown Requisition ID 2023-25513 Category Regulatory/Compliance Company (Portal Searching) FUJIFILM Electronic Materials U.S.A Overvi...
  • 10 Days Ago

N
Regulatory Reporting Analyst
  • Neighborhood Health Plan of Rhode Island
  • Smithfield, RI OTHER
  • Job Details Job Location: Smithfield, RI - Smithfield, RI Position Type: Full Time Education Level: Bachelors Degree Salary Range: Undisclosed Travel Percentage: None Job Shift: Daytime Job Category: ...
  • 22 Days Ago

Rhode Island (/ˌroʊd -/ (listen)), officially the State of Rhode Island and Providence Plantations, is a state in the New England region of the United States. It is the smallest state in area, the seventh least populous, the second most densely populated, and it has the longest official name of any state. Rhode Island is bordered by Connecticut to the west, Massachusetts to the north and east, and the Atlantic Ocean to the south via Rhode Island Sound and Block Island Sound. It also shares a small maritime border with New York. Providence is the state capital and most populous city in Rhode Is...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Manager jobs
$143,983 to $203,085

Regulatory Affairs Manager in Wichita Falls, TX
Other names for this job might include Clinical Trials Systems Administrator, Global Regulatory Affairs Manager, Regulatory Administrator, Regulatory Affairs Director, Regulatory Affairs Manager, Regulatory Affairs Portfolio Leader, Regulatory Consultant, Regulatory Leader, Regulatory Process Manager, Regulatory Product Manager.
January 17, 2020
Regulatory Affairs Manager in Baltimore, MD
Lead strategic contributions and initiatives to develop regulatory services and improve current processes and procedures.
January 18, 2020
Regulatory Affairs Manager in Fort Lauderdale, FL
Regulatory Domain Support for business development, including solutioning and developing innovative solutions, creation of materials for and participation in sales pursuits, key client meetings, bid defences for RFIs and RFPs.
December 04, 2019