Regulatory Affairs Specialist (BB-B6973)
Found in: Neuvoo CA
Description: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 Canadahttps://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 support the Product Development Teams inachieving market clearances for our medical software products internationally.
• Supports the creation of Regulatory Strategies and Plans in thedomestic and international markets, including assessments of the regulatoryimpact of changes.
• Responsible for the compilation, submission and maintenance ofregulatory filings for our software products according to internationalguidelines. and timely market access of new products.
• Responsible for regulatory review of marketing materials of ourproducts.
• Provide support in audits and inspections by regulatoryauthorities and certification/accreditation bodies.
• Displays a high level of critical thinking in bringing successfulresolution 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 berequired in some areas.
• 3 –5 years’ experience working with Medical Devices and trackrecord of international regulatory filings.
• Has knowledge and experience with regulations and standards (i.eQSR, MDSAP, EU MDD & MDR, ISO 13485, ISO 9001, IEC 62304, ISO 14971,IEC 62366 etc).
• Strong interpersonal, communication and organizational skillsrequired.
• Must be able to set priorities as well as adapt to changingpriorities.
• Experience with Health Software and Agile methodology is a plus#LI-RW1
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