MillenniumSoft Inc ยท 2 weeks ago
Senior Regulatory Affairs Coordinator - Onsite
Irvine, CA
Full-time
Onsite
Senior Level
5+ years expMillenniumSoft Inc is a company specializing in regulatory affairs for medical devices. They are seeking a Senior Regulatory Affairs Coordinator to support US and EU regulatory submissions, develop regulatory strategies, and guide business units on registration requirements.
Staffing & Recruiting
No H1B
Responsibilities
Support US and EU regulatory submissions (exercising judgment to protect proprietary information); track timelines and document milestone achievements
Participate in assessing and collating regulatory impact and developing regulatory strategy
Collaborate and approve change requests/change notifications
Participate in providing guidance and feedback to business unit regulatory teams on registration requirements for new and renewal registrations, product and process changes, and labeling content
Other incidental duties assigned by Leadership
Qualification
Required
Support US and EU regulatory submissions (exercising judgment to protect proprietary information); track timelines and document milestone achievements
Participate in assessing and collating regulatory impact and developing regulatory strategy
Collaborate and approve change requests/change notifications
Participate in providing guidance and feedback to business unit regulatory teams on registration requirements for new and renewal registrations, product and process changes, and labeling content
Coursework, seminars, and/or other formal government and/or trade association training required
Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel
Good written and verbal communication skills and interpersonal relationship skills
Good problem-solving, organizational, analytical and critical thinking skills
Solid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices
Solid knowledge and understanding of global regulatory requirements for new products or product changes
Strict attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast paced environment
Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects
Ability to build productive internal/external working relationships
Bachelor's Degree or equivalent in scientific discipline (e.g., Biology, Microbiology, Chemistry)
5-7 years of experience required
Company
MillenniumSoft Inc
Hire us to hire for you Staffing is not a straightforward activity.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Sailaja Mashetty
Partner - Customer Sucess
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