Jobs
>
Cambridge

    Regulatory Affairs Associate - Cambridge, Canada - Clarion Medical Technologies Inc.

    Clarion Medical Technologies Inc.
    Clarion Medical Technologies Inc. Cambridge, Canada

    2 weeks ago

    Default job background
    Description

    The successful applicant will:

    • Responsible for the maintenance and continual improvement of the company's quality systems (ISO 13485:2016, MDSAP (FDA/Canada), EU (MD).
    • Communicate with regulatory agencies regarding potential regulatory pathways, compliance requirements, or clarification and follow-up of regulatory filings or submissions under review.
    • Review, triage and confirm complaints as per defined criteria, ensuring customer complaints are received and processed appropriately and consistently to meet regulatory requirements
      Assign complaints to the appropriate subject matter experts for filed complaints that may require further investigation
    • Manage the Corrective Actions / Preventative Actions processes for all products in accordance with established company procedures including receiving, investigating and closing product complaints
    • Manage Quarantined inventory and investigating root origins to meet minimal threshold allowances
    • Complete key projects within the quality system such as traceability, vendor reviews, temperature monitoring, batch work processing and receiving inspections

    We are seeking a candidate with the following attributes:

    • Post-secondary degree/diploma (Sciences)
    • Experience working in an ISO 13485:2016 environment, as well as a good understanding of quality system principles
    • Post Market Surveillance experience is an asset
      • Computer literacy – including Outlook and Microsoft applications such as Word and Excel.
    • Ability to work independently
    • Flexible and strong organizational skills to manage time and productivity level to meet department metrics
    • High level of personal integrity is required
    • Excellent communication and interpersonal skills
    • Strong problem solving skills and attention to details
  • Clarion Medical Technologies Inc.

    Regulatory Affairs Associate

    3 weeks ago

    Clarion Medical Technologies Inc. Cambridge, Canada

    The successful applicant will: · - Responsible for the maintenance and continual improvement of the company's quality systems (ISO 13485:2016, MDSAP (FDA/Canada), EU (MD). · - Communicate with regulatory agencies regarding potential regulatory pathways, compliance requirements, o ...

  • FluidAI Medical

    Clinical Affairs Associate

    2 weeks ago

    FluidAI Medical Kitchener, Canada

    **Job Title: Clinical Affairs Associate** · **Company Description**: · FluidAI Medical is a medical device organization creating a paradigm shift in post-operative care, utilizing the plethora of data within the body, to help in the detection of post-operative complications at th ...

  • FluidAI Medical

    Regulatory Affairs Associate

    1 week ago

    FluidAI Medical Kitchener, Canada

    **Job Title: Regulatory Affairs Associate** · **Company Description**: · FluidAI Medical is a medical device organization creating a paradigm shift in post-operative care, utilizing the plethora of data within the body, to help in the detection of post-operative complications at ...

  • FluidAI Medical

    Regulatory Affairs Associate

    1 day ago

    FluidAI Medical Kitchener, Canada

    **Company Description**: · FluidAI Medical is a medical device organization creating a paradigm shift in post-operative care, utilizing the plethora of data within the body, to help in the detection of post-operative complications at their onset. Our clinically-validated platform ...

  • St. Joseph's Healthcare Hamilton

    Public Affairs Associate

    1 week ago

    St. Joseph's Healthcare Hamilton Hamilton, Canada

    Posting #: · **23510** · - Openings Remaining: · **1** · - Full/Part Time: · **Full Time** · - Reg/Temp/Casual: · **Regular** · - Union: · **Non-Union** · - Hours of Work: · **Monday to Friday; Days** · - Time of Day: · - Shift Length: · - Open Date: · **05/01/23** · - Closing Da ...

  • Lorandus Meetings & Communications

    Associate Project Manager

    2 weeks ago

    Lorandus Meetings & Communications Cambridge, Canada

    Lorandus Meetings and Communications is an Ontario-based boutique, third party event management & incentive travel agency. We excel in supporting our clients with the execution of meaningful and creative meetings, as well as partnering with them to enhance their talent retention ...

  • Bimeda

    Microbiology Manager

    2 weeks ago

    Bimeda Cambridge, Canada

    Bimeda is a leading global innovator, manufacturer and marketer of veterinary pharmaceuticals and animal health products and has over half a century's experience in providing science-driven solutions to optimize the health, wellbeing and productivity of the world's animals. Bimed ...

  • City of Cambridge

    Municipal Building Official

    1 week ago

    City of Cambridge Cambridge, Canada

    **People, Place, Prosperity**: · **Job Profile**: · The City of Cambridge is growing and so is our team We're seeking an experienced Municipal Building Official working within the Community Development Department, Building Division available immediately. Reporting to the Manager ...

  • Carter's

    Human Resources Manager-canada

    1 week ago

    Carter's Cambridge, Canada

    QUESTIONNAIRE-3-81 · 3903 · **Serving the needs of all families with young children, **Carter's Inc. is the largest North American apparel retailer exclusively for babies and young children, encompassing Carter's, OshKosh B'gosh, Skip*Hop and Little Planet brands. Meaningful work ...

  • Carters

    Human Resources Manager-canada

    1 week ago

    Carters Cambridge, Canada

    Human Resources Manager-Canada · QUESTIONNAIRE-3-81 · 3903 · **Serving the needs of all families with young children, **Carter's Inc. is the largest North American apparel retailer exclusively for babies and young children, encompassing Carter's, OshKosh B'gosh, Skip*Hop and Litt ...

  • Cambridge Memorial Hospital

    Patient Experience Lead

    1 week ago

    Cambridge Memorial Hospital Cambridge, Canada

    Overview: · Join a hospital where everyone makes a difference Cambridge Memorial Hospital (CMH) is a thriving community hospital that proudly provides acute care services including: Emergency, Surgery, Medicine, Women's and Children's Health, Intensive Care, Mental Health, and In ...

  • Bimeda

    Compliance and Microbiology Manager

    1 week ago

    Bimeda Cambridge, Canada

    Bimeda is a leading global innovator, manufacturer and marketer of veterinary pharmaceuticals and animal health products and has over half a century's experience in providing science-driven solutions to optimize the health, wellbeing and productivity of the world's animals. Bimed ...

  • Trouw Nutrition

    Regulatory Affairs Officer, 1 Yr Term

    3 weeks ago

    Trouw Nutrition Puslinch, Canada

    This role may be based anywhere in Canada and is open to hybrid working environment. Term. to March 2024. · If you are excited about joining an awesome team that's focused on defining strategies for registration and authorization of selected products within Canada as well as iden ...

  • Wilfrid Laurier University

    Manager, Student Affairs Communications

    2 weeks ago

    Wilfrid Laurier University Waterloo, Canada

    **Date**:May 15, 2023 · **Location**: Waterloo, CA · **Company**:Wilfrid Laurier University · **Department**: Student Affairs · **Job Type**: Continuing · **Full-time/Part-time**: Full Time (>=1249 hrs/year) · **Campus**: Waterloo · **Reports to**:Associate Director, Strategic Op ...

  • Conestoga College

    Case Manager, Student Affairs

    2 weeks ago

    Conestoga College Kitchener, Canada

    **Requisition Details**: · - **Job Title**:Case Manager, Student Affairs (Contract)**: · - **Requisition #**:24-0415**: · - **Location**: Doon · - **Department**: Student Rights & Responsibilities · - **Payband**: 10 · - **Payband Range**: $85, $106,911.00 · - **Hours/Week**: 37. ...

  • Campus Living Centres

    Residence Life Manager

    2 weeks ago

    Campus Living Centres Kitchener, Canada

    **1. Position Summary and Job Magnitude** · The Residence Life Manager (RLM) is responsible for creating a safe, inclusive and enriching student experience in residence. The RLM is responsible for the development and implementation of the residence life program that supports stud ...

  • University of Waterloo

    Graduate Program Coordinator and Advisor

    2 weeks ago

    University of Waterloo Waterloo, Canada

    Overview: · The Graduate Program Coordinator and Advisor is responsible for effective and efficient administration of the graduate program in Chemistry. This role is responsible for ensuring the smooth day-to-day, term-toterm and year-to-year operation of the departmental graduat ...

  • University of Waterloo

    Administrative Manager, Undergraduate Office

    2 weeks ago

    University of Waterloo Waterloo, Canada

    Overview: · **Term: 9 Months** · The Administrative Manager is responsible for the effective management of all non-academic aspects of the Arts Undergraduate Office within the framework of the Faculty of Arts and University of Waterloo. They are responsible for strategic planning ...

  • University of Waterloo

    Graduate & Admissions Coordinator

    2 weeks ago

    University of Waterloo Waterloo, Canada

    Overview: · **Term: 1 year** · The Graduate & Admissions Coordinator administers academic services and advises graduate students in the Centre for Computational Mathematics in Industry & Commerce (CCMIC) (50%) and the Department of Applied Mathematics (AM) (50%) graduate programs ...

  • Conestoga College

    Sport & Recreation Media Coordinator

    2 weeks ago

    Conestoga College Kitchener, Canada

    **Requisition Details**: · - **Job Title**:Sport & Recreation Media Coordinator**: · - **Requisition #**:23-1259**: · - **Campus**: Doon · - **Department**: Varsity & Athletics Operations · - **Payband**: H · - **Starting Rate**: $35.06 · - **Payband Range**: $ $40.71 · - **Hours ...