About UsSynaptive Medical is a Canadian medical device company, based in the Greater Toronto Area (Mississauga, Ontario), providing advanced precision imaging and intervention technology for improved diagnosis and treatment. Synaptives suite of products include Magnetic Resonance Imaging (MRI) systems, surgical planning, navigation, and robotic visualization. These products can be seamlessly combined or used independently in the operating room to improve detection and treatment for oncology, stroke and neurogenerative patients. The company has a global footprint of high-profile customers operating 24-7 for the betterment of all patients.About UsSynaptive Medical is a Canadian medical device company, based in the Greater Toronto Area (Mississauga, Ontario), providing advanced precision imaging and intervention technology for improved diagnosis and treatment. Synaptives suite of products include Magnetic Resonance Imaging (MRI) systems, surgical planning, navigation, and robotic visualization. These products can be seamlessly combined or used independently in the operating room to improve detection and treatment for oncology, stroke and neurogenerative patients. The company has a global footprint of high-profile customers operating 24-7 for the betterment of all patients.The company has several opportunities for passionate and innovative people to join the team and share in the development of technologies to solve surgical and imaging challenges in patient care.Regulatory Affairs Specialist Co-opThe OpportunitySynaptive is looking for motivated people to join the team and share in the challenges and rewards of developing technologies to improve patient care and outcomes in neurosurgery. We are seeking a qualified person to support growth and maintain regulatory compliance with our product portfolio in global markets. The Regulatory Affairs Specialist will assist the Regulatory Affairs Lead in generating post-market surveillance reports and assist with the creation and compilation of regulatory submissions to the FDA, Health Canada, EU and other international regulatory bodies. As a member of the Regulatory Affairs team, you will provide regulatory support for regulatory development and RnD software, visualization technologies and electromechanical medical devices projects. This is a hands-on role that may require you to roll up your sleeves from time to time and be a supportive team member. We need individuals who will feel comfortable in a fast-paced environment.This is primarily an on-site role with the opportunity for remote work when timelines and deliverables permit. This posting is for a 12-month co-op term with the possibility of extension.What Youll DoAssist in the preparation, compilation, and submission of regulatory applications for product approvals domestically and internationallyConduct post market surveillance activities on existing and new productsMaintain and update CE Technical FilesReview submission materials including labeling and technical documentationAssist with change orders for the Regulatory departmentMaintain and update global product listings, facility and establishment registrationsDraft sections of DHF and work closely with project teams for development projects to provide regulatory support and regulatory change assessments to determine filing needsReview complaints for regulatory reporting, recalls, or CAPAsAssist in responding to requests for additional information from regulatory authoritiesReview, write and contribute toward departmental SOPsParticipate in quality systems audits as a regulatory SME as requiredStay abreast of regulatory procedures and changes in regulatory climate and update departmentProvide support with day to day departmental activities as requiredWhat Youll NeedRegistered in Post-secondary Electrical, Systems or Biomedical Engineering, Life Sciences degree or equivalent. Advanced degree highly preferred1-3 years of medical device experience in a similar roleStrong attention to detail and problem-solving skillsItd Be Amazing If You HadExperience with complex regulatory submissions in different jurisdictions (i.e., Health Canada, CE, Asia Pacific)Familiarity with FDAs medical device regulations, SOR/98-282, EU MDR, ISO standards, etc.Experience with Electromechanical devices such as Medical Imaging Systems, Medical Device Navigation Software, Robotics, SaMD, etc. will be an assetFormal education or certification in Regulatory AffairsAbout YouFriendly and positive attitudeExcellent written and verbal communication skillsSelf-motivated and self-managingExcellent attention to detailAbility to work in a highly technical, fast-paced environmentAbility to take ownership of a problem and see it through resolutionAbility to communicate clearly and effectively with technical team members in order to capture and document various regulatory submission materials such as technical files and 510k documentationAbility to distill complex concepts into clear messagingPay range between $20.00 and $28.00 per hourArtificial Intelligence (AI) in Recruitment and SelectionSynaptive may use AI enabled tools to support certain administrative aspects of its people and talent processes, such as organizing application or scheduling. These tools are used to assist our teams and do not replace human judgement.Diversity & InclusivitySynaptive is based out of one of the most diverse countries in the world. This includes differences related to race, ethnicity, national origin, gender, gender expression and presentation, sexual orientation, religion, age, ability and socioeconomic status. To us, diversity is one our strongest assets to our organization. We commit ourselves to promoting the recognition and appreciation of our diverse and rich culture. We believe that it is critical to our success to promote freedom of thought and opinion in a respectful environment. The decisions we make are rooted by respectfully considering each others thoughts and opinions and by working towards a greater common goal, saving lives.AccommodationSynaptive Medical is an equal opportunity employer and welcomes applications from all qualified individuals, including visible minorities, Indigenous People, and persons with disabilities. We welcome and encourage applications from people with disabilities. If as a qualified job applicant, you request accommodation, Synaptive will consult with you to provide reasonable accommodations according to your specific needs. If you wish to make a request, you will be provided an opportunity if your application is selected to proceed in our hiring process.How to ApplyUnless otherwise stated, applications will only be considered from candidates eligible to work in Canada, or the country in which theyre applying to, without sponsorship.If you are interested in this position and can demonstrate that you meet or exceed the requirements defined in the job description, please include #GOBRAIN in the top right corner of your resume and then complete your online application by clicking Apply Now and following the prompts.The successful candidate to this role will be asked to complete background checks, which may include criminal, credit, employment and/or educational checks. All offers of employment are conditional on the receipt of satisfactory results of any applicable background check.We would like to thank everyone who submits an application. Due to the volume that we receive, only those candidates selected for interviews will be contacted. #J-18808-Ljbffr
Job Title
Regulatory Affairs - CO-OP