Scube Systems considers its employees to be a paramount asset. We put a significant focus on developing leadership at all levels of the company. At Scube Systems you work in an environment where you have exposure to some of the world’s leading companies across multiple industries. Gain valuable experience while providing world class support for the industry’s products. Start a career on the cutting edge of the technology and the work in the atmosphere that is fast-paced, exciting and rewarding. 

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We are currently hiring for the following positions

1. MDR/IVDR Regulatory Affairs Specialist

Guide and support the EU MDR Program and the Business Groups in EU regulations. This involves being a confident advisor on regulatory strategy, lobbying, regulatory compliance and quality management related topics, in order to achieve systems and product compliance to the EU MDR by May 2020 and IVD by May 2022 as well as to support other laws, regulations and standards impacting safe and effective utilization in the EU.
Your responsibilities will include but are not limited to the following:
  • Own and drive activities within the EU MDR Program as a Subject Matter Expert. Define and support training with information/guidance documents on MDD/MDR/IVDR/MEDDEV 2.7/rev4 as appropriate within the businesses and supporting functions. Consultation on MDR/IVDR (internally & externally) to drive position and maintain awareness of industry (competitor) positioning
  • Help identify key priorities and decisions to enable the organization to capture key opportunities to reduce risk and improve performance on implementation of EU MDR/IVDR Program
  • Monitor the implementation of the new EU MDR/IVDR requirements and identify any key risk areas and mitigation activities within business and supporting functions to ensure compliance prior to May 2020 and May 2022 deadlines.
  • Support standards team on analysis, interpretation and dissemination of information as it applies to the EU MDR.
  • Serve on national and international standards committees and industry organizations that establish or influence requirements on medical products/solutions (i.e. Participate in COCIR and MedTech Europe representing Philip and Leadership in Key Committee(s) representing industry)
  • Leverage well developed interpersonal skills to build and maintain positive working relationships with functional groups throughout the organization
  • Support internal program and external communication, which includes content and planning for communications cascades, and supporting review / feedback.
  • Demonstrated track record of team leadership, building teams, relationship management, and business development,· including virtual teams
  • Strong communication, interpersonal and presentation skills; detail-oriented·
  • Proven experience in a matrix management of multiple operations·
  • Ability and willingness to travel both domestically and internationally up to 25% of the time

2. Project Management (Clinical , IVDR)

The Project Manager is responsible for the planning, scheduling, tracking, coordinating, and monitoring of clinical technical files to ensure timely completion and approval of those files for compliance with IVDR regulations. S/He will work with and report to the IVDR Implementation Team Lead.

As a Project Manager, Responsibilities Include:

  • Work with a cross-functional team to ensure the required documentation is properly completed in support of regulatory submissions for in vitro diagnostic products
  • Track progress of each clinical portion of Technical File to confirm all deliverables are met and are in compliance with IVDR requirements
  • Capture gaps, and manage activities to verify closure of clinical affairs tasks
  • Resolve issues that arise within the clinical team
  • Ensure that the project stays on schedule
  • Support the IVDR Implementation Team Lead in managing completion of Technical Files, working closely with the IVDR Project Lead Qualifications
  • Project Management Professional (PMP) certification not required but is a key differentiator
  • Strong IVDR and / or MDR understanding and working knowledge
  • Knowledge and experience with global registrations of in vitro diagnostic devices or medical devices a plus
  • Must be able to set priorities as well as adapt to changing priorities Ability to function in a changing, high-impact position, with deadline and resource constraints
  • Demonstrated effective written and oral communications skills.