Job Details

  • Title: Regulatory Affairs Manager
  • Code: RCI-83613
  • Location:
  • Posted Date: 07/29/2020
  • Duration: 4 Months
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  Job Description

These positions will be very hands on working on technical files and labeling for IVDR. Must be able to work with cross functional team and have strong time management skills. Experience with IVDR is a plus.

The position is 100% remote role

Important Updates from the manager

  • Candidate would be working on clinical evaluation reports
  • Candidate would be writing a lot of submission work
  • 5-7 yrs of experience needed
  • Looking for industries experience that perform this IVD test
  • Not looking for some one that has taken out the files from repository and that kind of experience. Looking for writing experience with technical reports
  • Bachelors degree needed
  • Looking for some one to help and complete the project
  • Experience with technical file writing software products or annex 2
  • Must have IVDR experience
  • Looking for Medical dev experience or implantables or any thing along those lines
Responsibilities:
  • Determine requirements for regulatory submissions
  • Manage direct reports for successful execution of regulatory plans
  • Maintain current knowledge of relevant regulations, including proposed and final rules
  • Review labeling/promotional/advertising materials, and other documents to ensure compliance
  • Develop, manage, and execute regulatory plans for large-scale projects
  • Manages teams within the Regulatory Affairs Sub-Function.
  • Focus is on policy and strategy implementation and control rather than development.
  • Typically handles short-term operational/tactical responsibilities.
  • As the Manager of the Regulatory Affairs Sub-Function, oversees the strategy implementation and operations for directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
  • Interacts with regulatory agency to expedite approval of pending registration.
  • Serves as regulatory liaison throughout product lifecycle.
  • Participates in product plan development and implementation, regulatory strategy, risk management.
  • Ensures timely approval of new medical devices (IVDs) and continued approval of marketed products.
  • Serves as regulatory representative to marketing, research teams and regulatory agencies.
  • Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.

Required Education and Experience:

  • BA/BS degree is required. Previous in vitro diagnostic (IVD) nucleic acid experience highly preferred
  • Previous experience with 510(k), IDE, and/or PMA submissions
  • Demonstrated initiative and ability to work both independently and as a team member;
  • Considerable knowledge of the pertinent regulations affecting IVD’s (ie: QSR, Labeling, International Standards and Directives);
  • Solid analytical, problem solving and public relations skills;
  • Excellent English communication skills;
  • Strong organizational skills with a proven ability to drive for results;
  • Project Management and/or Supervisory experience is an asset;
  • Intermediate skills in MS Office (Word, Excel, Powerpoint)
  • Ability to take key actions and demonstrate behavioral anchors the support all client leadership competencies.
  • Bachelor degree is required.
  • Experience working in a broader enterprise/cross-division business unit model preferred.
  • Ideally candidate has submission experience with FDA or Health Canada.