Ondine Biomedical is a global leader in photodisinfection which is a new technology that kills pathogens with light-activated agents. There is no potential for resistance formation which makes this ideal to help reduce antimicrobial resistance. It is effective against bacteria, fungi and viruses (including SARS).
We are still a small company but inspired to bring this technology to market to reduce healthcare acquired infections. We need you to come and grow with us as we enter into our next exciting growth phase.
In this role you will have the opportunity to save lives and decease risks for many patients and improving the future for all.
Company relocation benefits will not be provided for this position. For this position, you will reside in or within commuting distance to Bothell, WA.
BA or BS degree in a technical discipline
Experience with either 510(k) applications, PMA supplements and US device regulations and experience with EU submission and other international medical device regulations and submissions
Must be familiar with regulatory requirement for medical devices in the US and EU (at a minimum) including Quality Systems and ISO standards
Strong verbal and written communication skills with the ability to effectively communicate at multiple levels in the organization,
Ability to identify and solve problems and work independently with little oversight
Ability to work in a highly matrixed and geographically diverse business environment
Ability to work within a team and as an individual contributor in a fast-paced, changing environment
Ability to leverage and/or engage others to accomplish projects
Multitasks, prioritizes, and meets deadlines in timely manner
Strong organizational and follow-up skills, as well as attention to detail
•This position performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the US, Health Canada and CE documentation, ensuring products and procedures comply with regulatory agency specifications
•Supports necessary regulatory activities required for product market entry
•Prepares robust regulatory applications/submissions and technical file documentation (either for FDA, Notified Bodies and Health Canada) to achieve departmental and organizational objectives
•Conducts reviews of product and manufacturing changes for compliance with applicable regulations
•Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the development team
•Work with cross-functional team to support product release process
•Reviews protocols and reports to support regulatory submissions
•Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements
•Complies with U.S. Food and Drug Administration (FDA), Health Canada and EU MDR regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments
•Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
•Performs other related duties and responsibilities as assigned
Located near Seattle, WA
Company makes medical devices and combination products using a novel technology. Currently approved by Health Canada, CE mark, and other approvals. Working on MDR compliance. MDSAP for several years. Several pipeline products - Class 2. Small company with the opportunity to wear several hats and acquire cross functional experience.