Regulatory Affairs Specialist

Job description

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.

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 

The Regulatory Affairs Professional (RA Specialist) supports the Siemens Healthineers Business Lines (BL) by analyzing the Health Canada (HC) requirements and preparing/filing Class I – IV medical device (in-vivo & in-vitro) regulatory submissions to ensure commercial availability in the Canadian market.

Acts as the RA subject matter expert and coordinates regulatory projects, project schedules and the product introduction process for Siemens Canada Ltd; participates in the decision making process on regulatory submission issues using historical knowledge and current Canadian regulations regarding the medical device industry; act as the liaison between Health Canada and the BL manufacturing facility; represent Siemens in Industry meetings; and acts as a valued contributor on the Canadian Regulatory Affairs team. 

The RA Specialist position reports to Siemens Healthineers North America (NAM) RA management and works closely with the fellow NAM RA/CA Specialists, BL Regulatory and Manufacturing and with NAM BLs, to align regulatory submissions’ objectives with the Canadian business needs. This includes interfacing with multiple functional areas, geographies and divisions and collects and reports on the organization KPI metrics.

Position Description

·  Identifies, analyzes and implements specific regulatory requirements for product related submissions for HC Class I – IV (in vitro & in vivo) medical devices 
·  Plans and prepares HC medical device licence applications with the BL RA teams, according to the regulatory requirements and aligned with the Canadian business needs
·  Screens all product submissions from Siemens BLs and OEM suppliers to ensure accurate applications to identify non-compliance issues and educate/advise internal customers on Health Canada legislation and policies
·  Finalizes and submits HC medical device licence applications per the agreed-upon business timelines
·  Initiates and escalates necessary activities if deviations are identified
·  Accepts Regulatory process ownership and creates quality guidelines and work instructions relevant to maintain regulatory compliance
·  Provides key performance metrics data as required to keep department reporting current and accurate
·  Monitors changes to legislation policies and guidelines and interpret how the changes impact the business
·  May participates and represent Siemens in Industry groups, acting as a subject matter expert (e.g. – Medtech, Advamed, etc.) 
·  Performs regulatory projects or acts as a member of a project steering group 
·  Performs review of promotional material for regulatory compliance according to country specific requirements
·  Acts as a valued contributor on the CAN Regulatory team, contributing to the team effort & awareness of expected value-add
·  Carries out duties in compliance with established business policies
·  Performs other duties and projects as assigned

Key Responsibilities:

 
Using professional expertise with functional, commercial and/or technical knowledge in regulatory affairs:

·  Contributes to and delivers business processes or detailed technology solutions, in a self-managed and target oriented manner, and thus contributes to team results
·  Focuses on analyzing, developing, testing or implementing processes, technologies and systems within regulatory affairs
·  May provide functional and regulatory advice and guidance to operational staff or colleagues

Knowledge

·  Using thorough professional know-how and experience with Health Canada premarket medical device submissions and regulatory affairs, focuses on applying and expanding acquired knowledge base and applying knowledge in a broader professional context
·  Identifies and implements improvements to existing processes and approaches

Influence

·  Provides specialized guidance or trains support and/or professional staff. Contributes to the success of the team by taking ownership and accountability for responsibilities for individual and team success.
 

Impact

·  Considers processes and results, generated in other workflows and disciplines, to contribute effectively to team results
·  Uses experienced level of analytical and distinctive conceptual skills to solve issues given, which may differ in size and nature

Experience

·  3 - 5 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
·  Solid knowledge of Health Canada Medical Device Regulations and associated guidance  
·  Successful demonstration of Key Responsibilities, Knowledge, Influence & Impact as presented above or equivalent education
·  Technical knowledge with Medical Devices In-vitro or In-vivo may suffice

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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