Website Siemens
Quality and Regulatory Affairs Engineer
Job Description
Quality & Regulatory Affairs Engineer
Siemens Healthineers is building tomorrow’s talent. Change the future with us.
We are looking for dedicated and talented people who tackle ever-changing challenges, customer needs, and questions from colleagues with clever concepts and creativity. We embrace change and work with curious minds re-inventing the future of work. Join us and let us focus together on what’s truly important: making lives better with new ideas and the latest technology around the world.
Why you’ll love working for Siemens Healthineers!
• Freedom and a healthy work- life balance– Embrace our flexible work environment with flex hours, telecommuting and digital wokspaces.
• Solve the world’s most significant problems – Be part of exciting and innovative projects.
• Engaging, challenging, and fast evolving, cutting edge technological environment.
• Opportunities to advance your career.
• Competitive total rewards package.
• Rewarding vacation entitlement with the opportunity to buy and sell your vacation depending on your lifestyle.
• Contribute to our social responsibility initiatives focused on access to education, access to technology and sustaining communities and make a positive impact on the community.
• Participate in our celebrations and social events.
• Opportunities to contribute your innovative ideas and get paid for them!
• Employee perks and discounts.
• Diversity and inclusivity focused.
• Siemens is proud to be an eight-time award winner of Canada’s Top 100 Employers, Canada’s Greenest Employers 2018 and Canada’s Top Employers for Young People 2019.
As a leading medical technology company, Siemens Healthineers enables healthcare providers to increase value by empowering them on their journey towards expanding precision medicine, transforming care delivery, improving the patient experience, and digitizing healthcare. Siemens Healthineers is continuously developing its product and service portfolio, with AI-supported applications and digital offerings that play an increasingly important role in the next generation of medical technology. These new applications will enhance the company’s foundation in in-vitro diagnostic, image-guided therapy, and in-vivo diagnostics. Siemens Healthineers also provides a range of services and solutions to enhance healthcare providers’ ability to provide high-quality, efficient care to patients.
Siemens Healthineers in Canada stands for engineering expertise with a pioneering spirit in exploring and developing business opportunities to help healthcare providers achieve their goal of improving outcomes while reducing costs. From the Atlantic to Pacific oceans, our 800 employees in Canada work together to deliver solutions for healthcare providers, resulting in 70% of medical decisions being influenced by the technologies we provide.
Our Impact:
• 70% of critical clinical decisions are influenced by the type of technology we provide
• More than 31 million Canadians benefit from Siemens Healthineers products every year
• An average of 85,000 Canadians per day receive treatment or tests from a Siemens Healthineers device
• Siemens Healthineers participates in 30 healthcare research collaborations in Canada
https://www.healthcare.siemens.ca/healthcare-company-profile/about
For this opportunity, the successful candidate will assist in defining regulatory strategies and driving quality policies, processes and procedures within the development of software medical device solutions.
The candidate will represent Quality Management on Product Development Teams (PDP) and/or Design Change Teams for our solutions and support in achieving market clearances internationally.
Key Responsibilities:
• Supports the creation of Regulatory Strategies and Plans for the PDP in the domestic and international markets, including assessments of the regulatory impact of changes.
• Responsible to ensure compliance to the quality management policies, processes and procedures are met through the product development, implementation and delivery.
• Responsible to monitor and manage quality activities are in compliance to regulations and standards throughout the development lifecycle.
• Responsible for the compilation and maintenance of regulatory filings according to international guidelines. and timely market access of new products
• Participates and or supports Quality management in recommending processes changes or risks that ensure alignment with strategic direction and or QMS compliance.
• Provide support in audits and inspections by regulatory authorities and certification/accreditation bodies.
• Able to manage multiple projects, communicate updates, and meet milestones in a timely fashion.
• Displays a high level of critical thinking in bringing successful resolution to high impact, complex, and/or cross functional problems.
Required Knowledge/Skills, Education and Experience:
• BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience. Certification may be required in some areas.
• 3 –5 years’ experience working with Medical Devices in Design Projects and successful demonstration of key responsibilities and knowledge as stated above.
• Has knowledge and experience with regulations and standards (i.e QSR, MDSAP, EU MDD & MDR, ISO 13485, ISO 9001, IEC 62304, ISO 14971, IEC 62366 etc).
• Experience managing Quality management system elements such as CAPA, Internal audit, Document Management, etc.
• Demonstrates a good grasp lean principles that can be applied through successful completion of assignments. Value stream mapping experience a plus.
• Strong interpersonal, communication and organizational skills required.
• Must be able to set priorities as well as adapt to changing priorities.
• Experience in Risk Management and/or Complaint Management is a plus
Organization: Siemens Healthineers
Company: Siemens Healthcare Limited
Experience Level: Experienced Professional
Job Type: Full-time
Siemens is committed to creating a diverse environment and is proud to be an equal opportunity employer. Upon request, Siemens Canada will provide reasonable accommodation for disabilities to support participation of candidates in all aspects of the recruitment process. All qualified applicants will receive consideration for employment.
By submitting personal information to Siemens Canada Limited or its affiliates, service providers and agents, you consent to our collection, use and disclosure of such information for the purposes described in our Privacy Code available at www.siemens.ca.
Siemens s’engage à créer un environnement diversifié et est fière d’être un employeur souscrivant au principe de l’égalité d’accès à l’emploi. Tous les candidats qualifiés seront pris en considération pour ce poste.
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