Regulatory Relations Specialist jobs in Cumberland, RI

Regulatory Relations Specialist files applications and interacts with governmental officials during the regulation and certification process for a plant or other facility. Assists in developing procedures to ensure regulatory compliance. Being a Regulatory Relations Specialist gathers data pertaining to organizational projects and their impact on the regulation process. May require a bachelor's degree. Additionally, Regulatory Relations Specialist typically reports to a supervisor or manager. To be a Regulatory Relations Specialist typically requires 4 to 7 years of related experience. Contributes to moderately complex aspects of a project. Work is generally independent and collaborative in nature. (Copyright 2024 Salary.com)

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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 with greater insight to quickly identify trends, rapidly and more accurately assess patient
    respiratory status, and make more well-informed, timely care decisions – decisions that can improve
    patient care. We aim to improve the lives of patients by advancing non-invasive patient care by
    empowering clinicians with clinically superior monitoring and therapeutic technologies.

    Watch the Sentec Company Video

    Summary:
    Responsible for registrations of Sentec products in the US and Canada, the Regulatory Affairs
    Specialist acts as the local representative and contact person for the competent authorities. Will work
    closely in conjunction with, and as an extension of, the Sentec regulatory compliance team based in
    Switzerland.

    Essential Duties and Responsibilities:

    • Continuous monitoring and implementation of updated regulatory requirements and
    standards relevant to Sentec products.
    • Support development of the regulatory strategy to receive product clearances in conjunction
    with Sentec Swiss regulatory team.
    • Compilation of submission dossiers for new product approvals and changes to existing
    approvals in close cooperation with internal and external stakeholders (e.g., regulatory
    consultants).
    • Serve as the primary local representative and contact to the FDA and Health Canada and other
    competent authorities.
    • Participate in regulatory inspections/audits by internal and external audit authorities and
    prepare formal responses as warranted.
    • Perform risk assessment of the obligation to report incidents and customer complaints in the
    US and Canada; Report incidents to the authorities and support the implementation of
    necessary measures internally (CAPAs) and in the market (FSCAs).
    • Support partner companies (suppliers, dealers) regarding regulatory issues as needed.
    • Act as regulatory representative on cross-functional project teams to develop regulatory

    strategies, testing requirements, and other documentation to ensure that regulatory
    submissions are prepared and approved to meet launch timelines for new and modified
    products.

    • Review product, supplier, and manufacturing changes as well as verification and validation
    activities, for compliance with applicable regulations and procedures.
    • Support Quality teams by providing guidance and serving as a resource in the development
    and implementation of CAPA, internal audit and vendor/supplier audit programs..
    • Review and approve of labeling documents with focus of compliance to pre-defined claims and
    regulatory requirements.
    • Travel to Sentec facilities in North America and Switzerland as needed (anticipated 3-6 times
    annually)


    Qualifications and Education:
    • Bachelor’s degree required.
    • A minimum of 5 years’ experience in a Regulatory Affairs position specifically within the medical
    device industry.
    • In depth knowledge of the regulatory framework for medical devices with specific expertise for
    FDA and Health Canada/MDSAP.
    • Analytical thinking and ability to compile scientific data and summarize results.
    • Open-minded person with hands-on attitude and good team player.
    • Fluent in English.


    Life at Sentec
    Sentec employees have access to competitive benefits packages, paid parental leave, tuition
    reimbursement and more. Sentec offers a place to thrive and make an impact as a small company with
    huge potential and an expanding track-record of consistent growth. We know our decisions matter to
    the future of the company, our voices are heard by leadership and our hard work pays off.

    Sentec consists of an eclectic group of people dedicated to help deliver products to healthcare
    providers that make a difference and improve patient care. We love that we can log off each day
    knowing we’ve made a difference.

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

  • Just Posted

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Labor Relations Specialist - Remote
  • UNFI
  • Providence, RI FULL_TIME
  • Purpose: Provides support for the Labor Relations Department in in all aspects of Labor Relations. Job Responsibilities: Under the supervision of SVP of Labor Relations and other Senior Labor Relation...
  • 2 Days Ago

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Customer Relations Specialist
  • Big Brothers Big Sisters of Rhode Island
  • Providence, RI PART_TIME
  • Position SummaryThe Customer Relations Specialist is an integral part of our program team, dedicated to providing exceptional support and fostering positive relationships with our valued participants....
  • 2 Days Ago

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Employee Relations Specialist
  • Taco Family of Companies
  • Cranston, RI FULL_TIME
  • As a family-owned and operated company, we feel a special obligation to the employees who comprise our Taco family. We are committed to offering employees access to the tools necessary to live long an...
  • 7 Days Ago

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Employee Relations and Training Specialist
  • CW Resources
  • Plainville, MA FULL_TIME
  • National Travel up to 50% CW Resources is a national non-profit organization dedicated to creating an inclusive society where individuals with disabilities and those facing economic challenges have ac...
  • 1 Month Ago

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Kitchen Designer/Sales Consultant
  • RIHI The Kitchen and Bath Specialist
  • Warwick, RI FULL_TIME
  • In-Home sales: Kitchen DesignerRIHI is a full-service Kitchen and Bath Remodeling company specializing in residential remodeling. We have been family-owned and operated for 75 years. Our mantra is to ...
  • 2 Days Ago

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0 Regulatory Relations Specialist jobs found in Cumberland, RI area

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Regulatory Affairs Specialist
  • ConvaTec
  • Lexington, MA
  • Product Regulatory Affairs work includes: Directing submission development of product registration, progress reports, su...
  • 3/28/2024 12:00:00 AM

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Senior Regulatory Affairs Specialist
  • ConvaTec
  • Lexington, MA
  • Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologi...
  • 3/28/2024 12:00:00 AM

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Senior Regulatory Affairs Specialist - Hybrid
  • Becton, Dickinson & Company
  • Warwick, RI
  • As Senior Regulatory Affairs Specialist, you will will primarily focus on maintaining continued market access within our...
  • 3/28/2024 12:00:00 AM

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Senior Regulatory Affairs Specialist - Hybrid
  • BD (Becton, Dickinson and Company)
  • Warwick, RI
  • **Job Description Summary** As Senior Regulatory Affairs Specialist, you will will primarily focus on maintaining contin...
  • 3/28/2024 12:00:00 AM

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Data and Report regulatory specialist
  • Integrated Resources, Inc ( IRI )
  • Cambridge, MA
  • This is a hybrid or on site role Job Description : Summary / purpose of the position The nonclinical data and reports sp...
  • 3/28/2024 12:00:00 AM

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Regulatory & Compliance Specialist I
  • University of Massachusetts Medical School
  • Worcester, MA
  • Overview: POSITION SUMMARY: Under the direction of the Director or designee, the Regulatory and Compliance Specialist I ...
  • 3/28/2024 12:00:00 AM

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Senior Regulatory Affairs Specialist
  • Convatec Group PLC
  • Lexington, MA
  • Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologi...
  • 3/26/2024 12:00:00 AM

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Sr. Regulatory Specialist
  • Beth Israel Lahey Health
  • Boston, MA
  • **When you join the growing BILH team, you're not just taking a job, youre making a difference in peoples lives.** **Job...
  • 3/25/2024 12:00:00 AM

According to the United States Census Bureau, the town has a total area of 28.3 square miles (73.2 km2), of which 26.4 square miles (68.5 km2) is land and 1.8 square miles (4.7 km2), or 6.40%, is water. Cumberland is the easternmost town along the state's northern border with Massachusetts, making it the state's de facto northeasternmost town. Cumberland borders the Rhode Island cities of Woonsocket to the northwest and Central Falls, to the south and the town of Lincoln to the west as well as the Massachusetts towns of Wrentham to the north, Plainville and North Attleborough to the east and ...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Relations Specialist jobs
$78,164 to $107,305
Cumberland, Rhode Island area prices
were up 1.6% from a year ago

Regulatory Relations Specialist in Albany, GA
The Regulatory Relations Specialist is responsible for the execution of the overall strategy for regulatory engagement and enterprise-wide standards.  This includes assisting with the management of regulatory examinations, inquiries and meetings.  Additional responsibilities include.
December 09, 2019
Regulatory Relations Specialist in Monroe, LA
We are looking for a Marketing Specialist to plan, coordinate and manage marketing campaigns and activities across marketing channels.
February 06, 2020