Regulatory Affairs Specialist

Troy - Michigan - United States - Life Sciences & Health Care - Medical devices - Regulatory - Academic Bachelor

JOB PURPOSE:

To support day-to-day regulatory activities of assigned projects. This position is anticipated to be a 24-month temporary/contract position with future potential.

Feel free to contact

Arpita Sharma, Account manager

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About this role

RESPONSIBILITIES:

  • Manage multiple projects;
    • Maintain various tracking logs to ensure projects stay on schedule;
    • Escalate delayed activity to Regulatory Affairs Management;
      • Perform design history file searches in the electronic document management system;
      • Work with cross-functional teams to gather required documentation;
      • Review documents from various sources for completeness;
      • Compile regulatory submissions;
      • Perform miscellaneous tasks such as copying, scanning and filing;
      • Other various related activities.

      About you

      QUALIFICATIONS:

      • Bachelors Degree Required;
      • Microsoft Outlook & Calendar Management, Excel Spreadsheets, Microsoft Word and PowerPoint Presentations – able to create reports and manipulate data;
        • Knowledge of Adaptiv software (preferred);
        • Basic understanding of compliance and regulatory requirements (preferred);
        • Ability to work independently with limited supervision;
        • Strong analytical skills;
        • Flexibility – able to adapt to compliance cycle activities and demanding timelines;
        • Strong team player – will need to collaborate with Regulatory Affairs team, and other functional team members (on conference calls & in-house meetings);
        • Excellent written and verbal communication, and the ability to communicate effectively with all levels of the organization.

        Summary

        • Vacancy number: PUB205466
        • Location: Troy
        • Market: Life Sciences & Health Care
        • hours per week: 40
        • Branche: Medical devices
        • Education level: Academic Bachelor
        • Area of Expertise: Regulatory
        • Closing date: Monday, May 13, 2019
        Apply now

        Feel free to contact

        AS

        Arpita Sharma

        Account manager Brunel Canada Toronto

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