Coord 3, Regulatory Affairs - Exp in Medical Device ...

Position : Coord 3, Regulatory Affairs - Exp in Medical Device Indutry (Req Min 5-7 Yrs Exp)Location : Irvine, CADuration : 12 MonthsTotal Hours/week : 40.001st ShiftClient : Medical Devices CompanyLevel of Experience : Senior LevelEmployment Type : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPTJOB DESCRIPTIONKey Responsibilities:Support US and EU regulatory submissions (exercising judgment to protect proprietary information).Participate in assessing and collating regulatory impact and developing regulatory strategyCollaborate and approve change requests/change notifications.Participate in providing guidance and feedback to business unit regulatory teams on registration requirements for product and process changes.Other incidental duties assigned by Leadership.Additional Skills:Coursework, 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.Strict 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 representing the organization on specific projectsAbility to build productive internal/external working relationshipsEducation and Experience:Bachelor's Degree or equivalent in scientific discipline (e.g., Biology, Microbiology, Chemistry)5-7 years of experience required

Created: 2026-04-15