Regulatory Affairs Specialist
- Oakville, Canada
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 workspaces.
• 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 digitalizing 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.
• 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
In this role you will act as the regional Regulatory Affairs expert in Canada, supporting the Siemens Healthineers Business Lines (BL) by analyzing the requirements and filing Class I - IV medical device (IVD & Diagnostic Imaging (DI) submissions to Health Canada (HC).
Your key responsibilities will be:
- Providing expertise in strategy & planning of the medical device submissions
- Finalizing and submitting medical device license applications
- Initiating and escalating necessary activities if deviations are identified
- Managing communications with Health Canada and external partners managing regulatory submissions on behalf of the organization
- Providing regular reports to management on the status of regulatory submissions, licenses/clearances and registrations and submissions database management
- Tracking & updating key performance metrics data as required to keep department reporting current and accurate
- Assuming Regulatory process ownership by creating quality guidelines and work instructions
- Identifying and implementing continuous improvement initiatives
- Monitoring markets for regulatory changes to applicable regulations and requirements and communicate changes across the organization
- To participate in and represent Siemens in Industry groups and act as a subject matter expert (e.g. - Medtech, Advamed, etc.)
- Performing review of promotional material and labeling for regulatory compliance
- Performing other duties and projects as assigned
- Thorough professional experience with Health Canada premarket medical device submissions
- 4+ years' experience working in Regulatory Affairs with Health Canada Class I-IV premarket submissions; experience in Medical Devices and/or IVD (preferred)
- BSc or higher in Science or Engineering (preferred)
- Sound knowledge of Health Canada Medical Device Regulations and associated guidance
- Strong technical experience with IVD/DI Medical Devices (an asset) -RW1
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.
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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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