Senior Regulatory Affairs Specialist

6 days ago Be among the first 25 applicantsGet AI-powered advice on this job and more exclusive features.This range is provided by Infosoft, Inc.. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.Base pay range $55.03/hr - $55.03/hrDirect message the job poster from Infosoft, Inc.Job Title: Senior Regulatory Affairs SpecialistPay Rate: $50 to $55.03/HRDuration: 6 monthsLocation: Irvine, CA/Remote (9 am to 6 pm PST time zone due to frequent later afternoon meetings with Asia regions )Our Client is a Global medical device Manufacturer.We are looking for a Senior Regulatory Affairs Specialist to complete and maintain China and Hong Kong regulatory approvals and clearances of assigned products.Create regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by China and Hong Kong affiliates; track timelines and document milestone achievements, participate in developing regulatory strategy, and prioritize submissionsParticipate in providing guidance on strategies and contingency planning with respect to China and Hong Kong regulatory requirements, including assessing the impact of proposed and current global regulations and proposing suggestions for expediting approvals.Participate in representing the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving conflicts between those requirements and development issues, and/or reporting to management.Participate in providing guidance and feedback to business unit regulatory teams on registration requirements for new and renewal registrations, product and process changes, and review of labeling content. and guidance on process improvement projects, based on prior experience and responses from affiliates.Represent regulatory in the project team meetings, discussing project status and technical requests with China/Hongkong regulatory team, researching technical testing reports, drawings and communicate with R&D/ Quality teamsOther incidental duties assigned by Leadership.Must-have skills:Review of technical reports and submission dossiers, clear communication ( English and Mandarin ), and organization skills.Requirements:Bachelor's Degree or equivalent in a scientific discipline (e.g., Biology, Microbiology, Chemistry)5-7 years of experience preferred, experience with China regulatory registration required.Several years of experience in supporting China medical device registrations, type testing, and design changes.Understanding of China NMPA regulations,Experiences in type testing and China registrations, solid knowledge of US registration to quickly identify the technical information neededAdditional Skills:Fluency in Mandarin ChineseCoursework, seminars, and/or other formal government and/or trade association training requiredProven expertise in Microsoft Office Suite, including Word, PowerPoint, and ExcelGood written and verbal communication skills and interpersonal relationship skillsGood problem-solving, organizational, analytical, and critical thinking skillsSolid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devicesSolid knowledge and understanding of global regulatory requirements for new products or product changes.Solid knowledge of new product development systemsStrict attention to detailAbility to interact professionally with all organizational levelsAbility to manage competing priorities in a fast-paced environmentMust be able to work in a team environment, including inter-departmental teams, and represent the organization on specific projectsAbility to build productive internal/external working relationshipsAdhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others, as well as to the protection of the environment and prevention of pollution under their span of influence/controlSeniority level Seniority level Not ApplicableEmployment type Employment type Full-timeJob function Job function Health Care Provider and OtherIndustries Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Hospitals and Health CareReferrals increase your chances of interviewing at Infosoft, Inc. by 2xGet notified about new Regulatory Affairs Specialist jobs in United States .Regulatory Compliance and Contracts Administrator (Remote - 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