Regulatory & Quality Consultant - Samd

Guide early-stage SaMD and medical device startups through regulatory and quality milestones—from first 510(k) filings to QMS buildout and Health Canada licensing.Rellia Health offers regulatory and quality consulting for early-stage startups. We work with medical device and SaMD companies at pivotal moments: their first 510(k), their first QMS, their first Health Canada licensing decision, the question of whether their software is a device at all. The clients who come to us are often navigating these questions for the first time, and they're trusting us to guide them through it.
Role DescriptionThis is virtual, project-based, independent contractor work. There is no minimum hourly commitment and you'll have complete flexibility in your working hours and hourly rate. In this position, you will guide clients on regulatory compliance and quality management systems specific to Software as a Medical Device (SaMD). Duties include developing quality management systems, conducting mock audits, analyzing regulatory requirements, advising strategies for compliance, and ensuring product documentation meets industry standards.
We're looking for a consultant to grow alongside us and who wants to be part of building something worthwhile.
QualificationsISO 13485 or MDSAP Quality Management Systems, especially those built for lean startupsIEC 62304 Software Development Lifecycle practicesFDA SaMD guidance documents or equivalent510(k), De Novo, or PMA submissions or equivalentCybersecurity and privacy regulationsYou understand what makes a QMS functional versus performativeYou can translate standards into practical systems that small teams can - actually maintainYou are comfortable presenting directly to customers and regulatorsExperience working in the health tech or medical device industryNo previous consulting experience is necessary
Who You AreCredentials and technical knowledge matter here, but the people we work best with tend to share a few less obvious traits.You Make Work Fun - A lot of clients are afraid that regulatory is painful and confusing. We keep the experience light, help founders gain confidence in their understanding of compliance, and try to have a good time while we do it.You Know When To Be Flexible - Compliance does not have to be rigid. We are open to creative approaches that fit startups and new ways of meeting requirements. We use automations and tech tools to keep things as easy as possible for everyone.You Work Efficiently - If we’re working with a startup with a tight budget, we do our best to keep our work as efficient as we can for them.You Provide Credibility - Our clients our using our suggestions and opinions to guide major strategic decisions, so they have to trust that we’re right. If we’re not sure about something, we rely on each other to get a second opinion.You Have Integrity - We’re are on the same team as our clients, not an adversary. We don’t work with jerks. Don’t be a jerk either.Role highlights
Develop quality management systems for Software as a Medical Device (SaMD) clientsConduct mock audits and analyze regulatory requirementsAdvise on FDA SaMD guidance, 510(k), De Novo, or PMA submissions and equivalentsApply ISO 13485 / MDSAP and IEC 62304 practices for lean startup teamsGuide cybersecurity, privacy, and product documentation to meet industry standardsPresent directly to customers and regulators with practical, maintainable compliance systems
#J-18808-Ljbffr