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Medical Device Design Assurance Specialist
2 months ago
StarFish Medical is a rapidly growing medical device design and development company dedicated to helping innovators create breakthrough products that improve health and save lives. With teams in Victoria and Toronto, we are seeking a talented and motivated Design Assurance Specialist to join our Quality Assurance and Regulatory Affairs team.
About the RoleWe are looking for a detail-oriented and proactive professional with proven experience in design and development processes, ensuring compliance with all relevant regulations and standards. In this hands-on role, you will collaborate closely with the System Engineering Team to ensure that complex, multidisciplinary products meet all regulatory requirements.
Key Responsibilities- Provide proactive input to projects, ensuring compliance and best practices for development are followed.
- Collaborate with external clients and internal colleagues to ensure QA/RA requirements and milestones are met.
- Draft and review DHF documentation with input from project teams, ensuring alignment with regulatory and quality standards.
- Participate in Engineering Design Reviews, providing input into regulatory strategy and compliance.
- Participate in risk management and requirements generation activities as needed.
- Provide input into testing documentation, including justifications for deviations, non-conformances, or exemptions.
- Communicate with internal teams and clients to resolve quality issues related to prototype release and disposition.
- Post-secondary education in a technical or science field, with a minimum of 3 years of work experience in quality assurance and/or regulatory affairs in a regulated environment, preferably medical devices, or an equivalent combination of education and experience.
- Working knowledge of ISO 13485, Canadian Medical Devices Regulations SOR/98-282, 21 CFR 820, EU MDR 2017/745, and FDA medical device regulations, especially 510(k).
- Award-winning culture with strong core values.
- Intrinsic reward – helping humanity through innovative medical devices.
- Profit-sharing.
- Excellent company-paid benefits package for you and your family.
- Paid vacation and sick leave, including a "vacation purchase program" to take more time off.
- Monthly All-hands meetings and social events that happen both during the workday and outside of work hours.
- 50% BC Transit / TTC cost-sharing in Toronto.
- Both locations offer shower facilities for midday runs or biking to work, and Victoria offers Galloping Goose access close by, while Toronto offers a Bike Share station within 5 minutes' walk to the office.
- Both locations offer free parking on-site or around the premises.
Our work environment received Canada's Most Admired Corporate Culture awards for 2021, 2022 & 2023, recognizing best-in-class cultures that have helped enhance performance and sustain a competitive advantage. We are Canada's leading medical device design service provider, providing a full complement of design, development, and low-contract manufacturing services in Victoria and Toronto. We successfully partner with innovative companies (both large and small) to create breakthrough products for several medical specialty areas.
We are dedicated to building a diverse, inclusive, and authentic workplace, so if you're excited about this role but your past experience doesn't align perfectly with every qualification in the job description, we encourage you to apply anyways. Please apply through the StarFish Medical Portal.
