Regulatory Affairs Specialist
Toronto, ON, Canada
Posted on Friday, January 19, 2024
Who We Are
Swift Medical is the global leader in digital wound care. We are a remote first organization headquartered in Toronto, with team members located across the U.S. and Canada. Our vision is to enable clinicians to provide better care to more patients in need with a mission to improve the standard of patient care by transforming personal devices into medical grade technologies.
We are the trusted wound technology partner of more than 4,000 healthcare facilities in North America across the continuum of care. Our solutions empower healthcare providers to deliver standardized, accessible and equitable wound care for every patient – with advanced, high-precision imaging, compliant documentation, clinical analytics and remote care.
In addition to the impact we are making in the healthcare industry and in the lives of patients, the best thing about Swift Medical is our exceptional people and our culture. Certified as a Great Place to Work®, what we do is not only inspiring, but we we are also a collaborative team working in an empathetic, energetic, and positive environment.
Our values guide us on our mission to transform patient care. We embrace them, and strive to embody them in all that we do. They are:
We are looking for a Regulatory Affairs Specialist to join our team at Swift Medical!
In this role, you will be working closely with a dynamic cross-functional team to ensure Swift continues to produce quality software and medical devices. You will play an integral part in developing regulatory strategies and processes as Swift looks to bring exciting new features and products to market. You will contribute to our organizational growth by supporting ongoing regulatory activities and future expansion into different markets with your strong understanding of global regulations.
How You Will Make An Impact
- Responsible for the preparation, compilation & assembly of domestic and foreign submission documents to government agencies (e.g. MDL, MDEL, 510(k), IDE, PMA, Technical Files, Dossiers, etc.)
- Development and implementation of regulatory strategies to support registrations of new or modified products
- Provide routine document management support and ensure that regulatory policies, SOPs, procedures and quality records are maintained
- Work collaboratively with R&D, Quality, Engineering, Clinical, Operations and other cross-functional teams on software and hardware design changes
- Support the product release process by reviewing and approving product release and technical documents
- Assists with ensuring compliance with post-market requirements such as recall notifications, problem reporting and Health Canada summary reports
- Reviews protocols and reports to support usability engineering and testing
- Lead in the understanding and awareness of regulatory requirements and monitor changes to policies and guidelines to interpret how the changes impact the business
- Performs additional duties and projects as assigned
What You Bring To The Table
- Completion of a Bachelor's degree
- 3+ years of regulatory experience in the medical device industry, and knowledge of Canada, US, and EU regulatory requirements
- Experience with writing 510(k) submissions and Letters to File
- Regulatory Affairs and Quality Operations Certificate is strongly preferred
- Experience with Software as a Medical Device (SaMD) is an asset
- Project Management experience is an asset
- Strong knowledge of ISO 13485, ISO 14971, IEC 62366, CMDR and FDA QSR requirements.
- Familiarity with MDR requirements for obtaining CE mark and other global regulatory jurisdictions
- Must have strong written and oral communication skills
- Must have a flexible mindset with the ability to work in a fast-paced environment
How We'll Be Interviewing For This Role
- Discovery and Culture Exploration (with our Manager, People)
- Leader Discussion (with our VP, Operations and Regulatory Affairs)
- Collective Insights (Panel) Discussion (with up to three members of the team)
Please note that this role is primarily remote. However, you will be required to be on-site to prepare for and support with regulatory audits in Toronto, ON from time to time.
Why Choose Swift
Unlimited Vacation Program
100% Paid Health, Vision, and Dental Benefits
Mental Health and Wellbeing Program
Continuous Growth Budget
Employee Stock Option Plan
Company Laptop & Work From Home Budget
Parental Leave Top Up Program
Mentoring and Development Opportunities
Remote-First Work (in Canada and the US)
The opportunity to transform patient care and be part of a world-class team
Not checking every box? Apply anyway! We'd love to learn more about you. We are an inclusive workplace that considers all applicants of diverse backgrounds and experiences. At Swift Medical, we are committed to providing equal opportunities and a sense of belonging for all team members, both present and future.
We celebrate diversity, and are dedicated to identifying and eliminating any barriers that may exist within our own hiring process, programs, and practices. Should you require accommodation throughout any stage of the interview process, please specify your requirements to email@example.com when submitting your application and we will work with you to accommodate your needs.
Please note: We are a remote team, and as such, all interviews will be conducted using Microsoft Teams.
We thank and appreciate all applicants for their interest. Only those selected for an interview will be contacted. Please no agency calls.