Are you interested in collaborating with a multidisciplinary team of scientists, clinicians and engineers who are creating artificial intelligence technologies to impact the lives of millions worldwide?
Our mission at MEDO is to democratize medical imaging by providing patients with efficient and affordable ultrasound expertise at the point of care. We use machine learning systems to radically simplify the way ultrasound scans are performed and interpreted, enabling all caregivers to make an accurate and confident diagnosis.
MEDO is a dual-headquartered med-tech startup with a team of over twenty clinicians, researchers, and developers who design and build software-as-a-medical-device (SaMD) products. We are backed by Wavemaker Partners as part of the Draper Venture Network, along with SG Innovate and major tech investors in the Asia-Pacific. Our innovations are currently being piloted in over 12 hospitals in 6 countries.
We are looking for a skilled and experienced Regulatory Affairs Manager to lead our compliance efforts in accordance with relevant regulations and standards. This challenging role is vital to the successful distribution and servicing of our technologies to healthcare providers around the globe. Our current team will need to grow to support these new responsibilities while simultaneously investing time in new innovations.
- Acting as the senior regulatory advisor across a variety of software projects, collaborating with project management and quality assurance personnel throughout the life cycles of each software product
- Working closely with MEDO leadership to determine regulatory priorities and pathways for each project on an ongoing basis
- Preparing and managing regulatory authorization, clearance, and licensing applications for the U.S., Canada, and Europe, along with documentation necessary for regulatory submissions (510(k), CE technical files)
- Acting as the primary regulatory point of contact for MEDO, bridging the gap between regulatory bodies and MEDO’s QA/QC and Business Development teams
- Proactively facilitating internal compliance audits and inspections
- Conducting training activities and promoting awareness with all team members of key quality and regulatory requirements at MEDO
- Providing regulatory insight and feedback into MEDO’s internal processes in order to consistently and efficiently deliver and maintain high-quality products
- Helping to integrate regulatory efforts within the entire product development lifecycle
- Planning, executing, reviewing, and tracking all Quality System events (change requests, CAPAs)
- Facilitating and managing post-market surveillance systems
- When required, assisting product teams with Design Control documents, including verification and validation protocols, clinical protocols, and risk assessments
- Reviewing and approving marketing and communication materials
- Staying current with changing medical device regulations, industry trends, and compliance requirements
- A minimum of 5 years of experience in medical device quality assurance and regulatory affairs
- A University Degree in a Science or Engineering field; a related Diploma with demonstrable hands-on experience will also be considered.
- Strong attention to detail, coupled with the ability to distill these details and communicate effectively with teammates (in both software-quality and business-development aspects)
- Direct experience with regulatory submissions - and corresponding regulations and laws - in the U.S. (510k, DeNovo, CFR QSR) and Europe (CE-marking, MDD and MDR). Experience working with regulatory agencies in the Asia-Pacific region is also an asset.
- Proficiency with using, maintaining, and auditing electronic Quality Management Systems in accordance with ISO 13485
- Experience with ongoing development and maintenance of medical device documentation
- Demonstrable knowledge of risk management standards and processes (ISO 14971)
- Experience with medical device security and software cybersecurity standards is a definite asset
- Relevant experience outside of the Regulatory Assurance field (ie: software development, quality assurance, image analysis, artificial intelligence systems) is highly desirable
- Previous startup experience and the ability to “wear multiple hats” at times is a definite asset
- You are a self-starter with a strong sense of urgency, who is always happy to take initiative and learn more!
As an established startup company, MEDO offers a dynamic, fast-paced environment that fosters independence, innovation, and many opportunities for challenge and professional growth. We are proud to embrace diversity and inclusivity: over one-third of our teammates are women and collectively we speak over ten different languages.