Senior Regulatory Affairs Specialist

Join us in pioneering breakthroughs in healthcare.
For everyone.
Everywhere.
Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality.
We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions. This is a role well suited to an ambitious professional, looking for the next step in their career.
This is a remote role. As a Senior Regulatory Affairs Specialist, you will be responsible to: * Prepare, submit, and maintain regulatory submissions and lifecycle documentation, including FDA 510(k) submissions and notes to file, IVDR Class C recertifications, significant change notifications, and other regulatory applications as required. * Serve as a Regulatory Affairs subject matter expert, providing guidance to design control activities and new product development teams. * Prepare, submit, and maintain Technical Files in compliance with applicable regulatory requirements and the Quality Management System (QMS). * Collaborate with cross-functional teams to develop and maintain quality guidelines, procedures, and work instructions that support ongoing regulatory compliance. * Independently or collaboratively lead and contribute to regulatory projects, ensuring timely execution and alignment with regulatory strategy. * Provide training to internal stakeholders on country-specific regulatory requirements, as applicable. * Independently or as part of a team, review promotional and labeling materials for regulatory compliance in accordance with country-specific requirements. * Ensure audit- and inspection-ready documentation and provide guidance to cross-functional teams on appropriate regulatory documentation practices. * Participate in internal and external audits, including quality system audits, design dossier reviews, and regulatory authority inspections, as applicable. This position may suit you best if you are familiar with what is below, and would like to do develop your career with Healthineers: * Solid working knowledge and experience of the US/EU regulations and standards applicable to medical device market clearance Knowledge of point-of-care IVD products and applicable regulations for such products * You have very good presentation skills, and you show team orientation and communication skills. * Ensure cross-functional collaboration and cooperation. * Excellent attention to details. * Able to multi-task and work effectively in a dynamic environment. * Nimble learning and have ability to actively seek out relevant legislation and competitive information on product lines. Required skills to have for the success of this role: * Bachelor's degree in scientific discipline * Minimum of 4 years of experience in IVDs or Medical devices * Skilled in Outlook, SharePoint, Adobe Acrobat, and Microsoft Office applications, including Excel and Azure DevOps * Experience of working in a GMP environment * Intercultural sensitivity * Strong attention to detail and excellent organizational skills The expected Compensation for this position is: $82,500- $117,500 CAD Factors which may affect starting compensation within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate. Siemens Healthineers offers a variety of health and wellness benefits including a flexible benefits plan, Defined Contribution Pension Plan, Registered Retirement Savings Plan matching contributions, plus a competitive paid time off program including vacation, company holidays, sick leave, and parental leave (all subject to eligibility requirements). This information is provided per required laws and regulations.
Applicants should apply via Siemens Healthineers external or internal careers site Who we are: We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries.
As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing.
Our portfolio is crucial for clinical decision-making and treatment pathways. How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual's potential to contribute with diverse ideas.
We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world's most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare.
For everyone.
Everywhere.
Sustainably. To find out more about Siemens Healthineers' businesses, please visit our company page at Siemens Healthineers Canada. Employment Opportunity Statement:Siemens Healthineers is committed to creating a diverse environment and is proud to be an equal opportunity employer.
While we appreciate all applications we receive, we advise that only candidates under consideration will be contacted. Accessibility: Siemens Healthineers is committed to excellence in serving all employees and customers, including people with disabilities.
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