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Quality and Regulatory Engineer

Tobii Dynavox, part of the Tobii group, is the world leader in eye tracking and speech generating devices - products that help individuals with speech and motor impairments live a richer and more independent life. Headquartered in Stockholm Tobii covers a global market with offices in USA, Germany, Norway, Japan and China. If you want to work with meaningful products and solve interesting problems, we might be the right company for you!

Take a look at this video that shows how we impact lives and give people with disabilities the power and ability to express who they are: https://www.youtube.com/watch?v=2zh2UMK8xf0

Our Pittsburgh office is located in the Southside. We offer our full time employees a generous benefits package including health/dental/vision, 401K with company match, paid vacations, 10 paid holidays, tuition reimbursement, free parking, relaxed work environment, free on-site gym, free bike rentals, and various company events.

JOB SUMMARY:

The Quality and Regulatory Engineer will be responsible for understanding rules and regulations to obtain and maintain global regulatory compliance for Tobii Dynavox products. Will assist in New Product Development projects, from the Design phase through the life of the products, and ensure that the products meet regulatory and quality control standards. Will be responsible for obtaining regulatory approvals and/or certifications for new products in global markets and provide regulatory support for changes to existing products of Tobii Dynavox.

THE ROLE AND RESPONSIBILITIES:

  • Act as the technical regulatory expert and “go to person” for all regulations (FDA, CE, FCC, CCC, ISO, CB Scheme, etc.) ensuring the necessary regulatory approvals and maintain regulatory compliance in all global markets served, including current and new markets for Tobii Dynavox’s product portfolio
  • Create procedures and guidelines to ensure that governmental and industry regulations are met in product designs for the different markets Tobii Dynavox will market their products
  • Hold responsibility for ensuring product compliance to applicable regulatory standards, including IEC60601-1 and collateral standards, IEC60950, FCC Part B, ICES, IATA, ISO, CE, WEEE, ROHS, R&TTE, CCC, etc
  • Hold responsibility for ensuring that risk management of products are done in accordance with the requirements of ISO 14971
  • Hold responsibility for leading and conducting usability and human factors studies, in accordance with the requirements of ISO 62366
  • Work with interdepartmental teams to develop product compliance specifications for products, materials, components, markings, labeling, and testing to meet regulatory, environmental, safety requirements and minimize cost and development time
  • Monitor and Keep departments up-to-date on new or revised regulations that may be relevant to product specification, such as for medical products, & IT-products Standards, EMC, Environmental and Safety
  • Responsible for regulatory filings and keeping records and other paperwork that may be required by regulatory bodies
  • Manage relationships within the relevant regulatory agencies, labs as may be required from time to time
  • Be able to assess suppliers engineering design processes and manufacturing processes to ensure that they are in compliance with required regulatory processes for the products that they produce
  • Assure control and proper disposition of nonconforming products and corrective actions
  • Maintain corrective & preventive action process and ensure timely follow-up, and implementation of corrective actions and handling of adverse events
  • Conduct quality system audits (including international audits) and assure compliance to required standards and that corrective action is performed
  • Conduct product reviews to ensure that products remain in compliance with regulatory requirements
  • Ensure critical information communicated to Functional Management on a regular basis
  • Shall manage multiple projects and activities and will not require supervision for day-to-day activities
  • Strong willingness to accept mandate to take action on issues determined to be at risk or out of compliance
  • Travel approximately 20% of time to Tobii Dynavox facilities and suppliers both domestic and international
  • Performs other duties as assigned

MINIMUM QUALIFICATIONS:

  • Bachelor’s degree in a technical discipline
  • 2 or more years of experience in some combination of Regulatory and Quality roles, some portion of which must include a manufacturing environment and medical devices, with at least 2 years with regulatory responsibilities
  • Experience working for a global organization with multiple sites and multi-national regulatory requirements is preferred
  • Knowledge of: FDA (including GMP), CE, and ISO strongly preferred
  • Ability to manage and report on projects and drive them to conclusion
  • Self-starter who works with a sense of urgency and acts as a good team player working with other disciplines
  • Strong communication skills - able to challenge, influence, and articulate a view and drive behavior or action
  • Strong technical writing skills – able to document procedures, processes, and responses to regulatory bodies in a manner that is concise and easy to understand
  • The ability to travel approximately 20% of time domestically and internationally

Key Technologies:

  • Proficient in basic computer navigation skills
  • Experience using MS Word, MS Excel, MS PowerPoint, MS Visio and Outlook
  • Experience using SharePoint is a plus

To be successful in this role and at Tobii Dynavox you need to be customer focused and interpersonal while collaborating and working with a team. You must be able to multitask in a fast paced environment.

All our jobs at Tobii Dynavox are about innovation, passion and not the least - making things real.

Working at Tobii Dynavox:

Working at Tobii is like being in the heart of innovation. Here you get to work on cool creative projects, together with passionate colleagues from all around the world.


Our technology brings a voice to people with speech impairments, it helps us understand human behavior and it is revolutionizing the way we interact with technology.


Life is short so we choose to spend it building high tech products that matters!


If you want to build a company rather than just work for one. If you take pride in honest, hard work and want to perform freely in an open environment where you can be yourself, you will feel right at home.


Tobii
- It’s all about passion, innovation and making things real –

Learn more about what we do by visiting our Youtube channel

EOE/AA Women/Minorities/Veterans/Disabled

Working at Tobii

At Tobii we love what we do - we work hard, play hard, and make every day exciting.

Learn more about what we do by viewing this short video Tobii in 3 minutes.