Regulatory Affairs Analyst

Origin Medical Research Lab seeks highly talented and self-motivated individuals ready to build impactful products to democratize quality prenatal care globally for every expecting mother. At Origin Medical Research Lab, we offer an empowering work environment that allows you to take full ownership of your work and fosters collaboration and personal growth. We look for exceptional individuals and outliers who want to join us on this mission. Embark on a purpose-driven career journey by joining our team.

About Origin Medical Research Lab

Origin Medical Research Lab is the research arm of Origin Medical. Here, we strive to bring together the best and brightest minds at the intersection of AI and healthcare to fulfill Origin Medical’s mission.

By combining the knowledge of healthcare and AI, it is on a journey to build state-of-the-art solutions aimed at supporting a broad spectrum of healthcare providers in rural and urban communities, allowing them to practice at the top of their licenses. With AI in the imaging workflow, clinicians can more confidently deliver timely interventions, enhance pregnancy outcomes, identify high-risk pregnancies to reduce maternal mortality, and significantly lower infant mortality rates.

Origin Medical, headquartered in Cambridge, Massachusetts, USA, is driven by a mission to advance maternal health equity by improving access to quality prenatal care with artificial intelligence.

About Regulatory Affairs Team and the Role

The Regulatory Team acts as a liaison between the potentially conflicting worlds of regulators, industry, and consumers to help make sure that marketed products are safe and effective when used as advertised. Functioning as an internal regulatory board for an ISO 13485:2016 certified organization, we ensure the organization’s quality assurance standards and regulatory guidelines compliance for all the processes that take place in the organization. Our aim is to foresee the impact of ever-changing regulations that would affect the organization’s compliance policies and reflect those for conforming to current guidelines and practices. Our team’s primary responsibility is to have oversight of all the teams and document the specific team’s procedures and practices. We additionally work on building the regulatory strategies for helping to establish a new standard of care on how pregnant mothers are safe, effective, and accurate to ultimately democratize quality prenatal care. By taking a proactive and forward-thinking approach, our team is helping the organization to commercialize and sustain the medical device in the market by adhering to regulatory compliance.

What will you do?

As a significant member of the Regulatory Affairs Team, you will work closely with external quality assurance auditors, U.S FDA regulatory professionals, and experts from across the world for planning the audits and getting our flagship product cleared by the U.S. FDA. Additionally, you will be working with the Clinical Research, Product, AI/Research, and Clinical Data team to build the product and commercialize it predominantly in the U.S. market.

• Ensure regulatory compliance of the company and product at all times: Recording country specific regulatory submissions by compiling submissions in a format consistent with applicable U.S. FDA guidance documents, technical writing, and analysis to support implementing quality assurance procedures for compliance, documenting device requirement specifications and planning and leading ISO 13485:2016 audits.
• Bringing the product to market through regulatory clearance (U.S. FDA): Work across all teams by giving strategic and regulatory advice and support, making important contributions commercially, technically, and scientifically to the success of the product’s commercialization.
• Documentation of current regulations: Have a close eye on changes in medical regulations and immediately document the relevant change in device regulations, additionally collect, collate, and evaluate scientific data.
• Document management: Maintain and update all the quality assurance and regulatory documentation, wherever and whenever necessary. Should work on managing and documenting information, and must be adept at working with databases and other information management tools.
• Interaction with regulatory bodies: Assist in preparing responses to regulatory authorities within assigned timelines to stay abreast of regulatory procedures and changes in the regulatory climate.
• Device comparable research: Develop strategies to search for comparable devices in the market of interest for commercialization.
• Build case studies and arguments: Should be able to infer from the regulations and build use cases, and arguments for the device under consideration.

Who are we looking for?

• Highly motivated individuals looking to build a career in the areas of medical device development and its regulations.
• Individuals who are passionate about medical AI and are keen to work across teams during every stage of product development and commercialization to ensure the product’s safety and effective functioning, on the last mile of healthcare AI product development (i.e., regulatory clearance).
• Ability to understand technical aspects of healthcare products, medical devices, and AI technology.
• Detail-oriented individual with good analytical and reasoning skills.
• Independent, creative self-starter, flexible, comfortable with ambiguity, and thrives in fast-paced work and highly collaborative environments.
• Good written and verbal communication skills with the ability to listen, articulate, and advocate.
• Proactive, high-performance, result-oriented, and manage projects with ethical integrity.
• Technical research and documentation skills (e.g. Analyzing FDA documents, preparing internal policies and documentation on Microsoft 365 applications).
• Understanding medical quality management systems like ISO 13485:2016, and ISO 14971:2019 is a must.
• Understanding of IEC 62304 is a plus.
• Knowledge of regulatory requirements pertaining to Software as a Medical Device (SaMD) and the FDA would be a plus.
• Manage multiple projects and deadlines.
• Ability to identify compliance risks and escalate when necessary.

Working at Origin Medical Research Lab

• You will receive competitive monthly compensation aligned with industry standards. Additionally, we provide a comprehensive benefits package, including Provident fund, Paid annual leaves, Sick leaves, Wellness allowance, and Insurance allowance.
• You will work with an exceptional team of highly qualified individuals who strive to deliver a product that improves the standard of care for expecting mothers everywhere.
• You will also collaborate with renowned clinicians, AI scientists, and business leaders from around the world.
• At Origin Medical Research Lab, we take pride in fostering an inclusive and optimistic company culture that places great value on collaboration, teamwork, and work-life balance. As a valued member of our team, you will have the opportunity to join a supportive environment where individuals genuinely care about each other's success and well-being. Our dedicated colleagues are always ready to lend a helping hand and wish you nothing but the best in your professional journey