Sunrise Systems, Inc. ยท 3 weeks ago
Regulatory Affairs - Coordinator 3
Irvine, CA
Full-time
Hybrid
Mid, Senior Level
$63/hr - $66/hr
5+ years expSunrise Systems, Inc. is a leading Medical Devices Manufacturing Company seeking a Regulatory Affairs - Coordinator 3 for a 12-month contract. The role involves supporting US and EU regulatory submissions, collaborating with regulatory teams, and developing regulatory strategies.
Information Technology & Services
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
Ability to manage competing priorities in a fast paced environment
Good problem-solving, organizational, analytical and critical thinking skills
Good written and verbal communication skills and interpersonal relationship skills
Knowledge and understanding of global regulations relevant to medical devices (Class II and/or Class III)
Knowledge of US and International regulations and standards that apply to the medical device industry, such as 21CFR820, ISO 13485, EU MDR, and MDSAP is highly desirable
5-7 years experience
Coursework, seminars, and/or other formal government and/or trade association training required
Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel
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
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)
Preferred
Experience with Windchill PLM and Adobe Acrobat
Has certificate in regulatory affairs
Benefits
Sunrise offers ACA compliant medical coverage/dental insurance/vision insurance to all employees.
We also offer Sick time benefits as required per State regulations.
Company
Sunrise Systems, Inc.
Sunrise Systems was founded in 1990 with a clear vision to deliver world-class staffing service solutions in all labor categories, including IT consulting and solutions; all with the commitment to provide service that exceeds expectations and become the most trusted name in the industry.
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
Ruchi Hajra
Senior Account Manager/Client Servicing/Talent Acquisition Partner
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