Job Description
Job Description
Company & Job Overview :
Diality Inc, a privately held medical device company located in Irvine, CA is committed to improving the quality of life for patients with kidney disease. We are developing a smart, flexible, portable hemodialysis machine that will enable patients to self-treat at home or wherever they travel. The extremely versatile hemodialysis solution will allow more patients to benefit from their true dialysis prescription at home or in a variety of care settings, including nursing homes, hospitals, and dialysis centers, without the need for pre-mixed dialysate bags or external water-treatment systems.
The Senior Regulatory Affairs Specialist represents the Regulatory Affairs function and is responsible for planning and executing regulatory activities necessary to obtain and maintain regulatory approvals within the United States and other countries. This position is also responsible for supporting the Quality Management System and will serve as the Regulatory Affairs representative on product teams.
Responsibilities :
- Prepare and coordinate submissions for new products and product changes to ensure timely approval for clinical studies and market release that include, but are not limited to, the following :
US FDA Investigational Device Exemption (IDE)
US FDA 510(k) and Pre-SubmissionsCE Marking under EU MDRProduct amendments to existing regulatory approvals / clearancesResponsible for obtaining and maintenance of, but not limited to, the following :Local, State and National Regulatory licensing and registration renewals
Import / Export PermitsProvide regulatory guidance and support to ensure adherence with global regulatory requirements as appropriate. Supports overall regulatory strategy during product development, manufacturing, and market launch.Provide regulatory support for marketed products as necessary. This includes reviewing labeling, promotional materials, changes to existing devices and documentation.Assesses product and manufacturing changes and develops regulatory assessments for each market as to impact upon current approvals. Prepares well-justified Letters to File (LTFs), based on a risk-based approach with considerations of regulatory pros and consSupport Quality Systems projects and activities such as, but not limited to, the following :Audits and inspections by regulatory agencies
Design Assurance activities, including Risk ManagementComplaint HandlingProduct Recalls and CorrectionsProduct adverse event reportingSupport Clinical and Commercial functions in post-market vigilance and clinical follow-up activities, including related regulatory reporting.Responsible for Medical Device Reporting, preparing FDA-Form 3500AProvide support to the Director on regulatory processes and templates and, as appropriate, provide training on these processes to team members outside of the regulatory function.Qualifications & Requirements :
Bachelor’s Degree with at least 8 years of regulatory affairs experience required in the MEDICAL DEVICE INDUSTRY .Certification in regulatory affairs (RAC) is preferred.US and EU medical device regulatory submission experience is required.Previous experience interacting directly with the FDA is required.Product development team experience along with experience reviewing and approving technical documentation.Broad-based technical knowledge and skills in diverse areas of business such as Engineering, Operations, Quality, Marketing, Clinical research, etc.The ability to effectively negotiate and influence cross-functional stakeholders, affiliates, and Regulatory agencies is a plus.Strong working knowledge of ISO 13485, FDA 21 CFR Part 820, and EU MDR regulations.Knowledge and understanding of other foreign country regulations and international device registration are a plus.Good knowledge of Clinical evaluation and investigation of medical devices.Expertise in Microsoft Office applications, such as MS Word and Excel.Excellent interpersonal skills including the ability to interact with a high degree of diplomacy.Excellent problem-solving skills, applied thinking skills, and technical writing skills.Excellent communication and organization skills are required.Ability to work in a fast-paced, technically challenging environment where drive is critical to success.A self-starter who is able to drive projects can assertively outline regulatory risks to cross-functional teams and has a “roll up sleeves” positive attitude.Experience in a start-up medical device environment with a combination of regulatory and clinical skill sets is preferred.Physical Demands :
Sustained periods of time standing and sitting at a desk working on a computerMust be able to liftWorking Environment :
Office or workstation environment (at least 3 times / week in the office).Travel :
Willingness to travel domestically as needed (up to 10%).
