What are the responsibilities and job description for the Senior Regulatory Affairs Coordinator - Onsite position at MillenniumSoft Inc?
Position : Senior Regulatory Affairs Coordinator
Location : Irvine, CA
Duration : 12 Months
Total Hours/week : 40.00
1st Shift
Client : Medical Devices Company
Level of Experience : Senior Level
Employment Type : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT
Job Description
Key Responsibilities:
Location : Irvine, CA
Duration : 12 Months
Total Hours/week : 40.00
1st Shift
Client : Medical Devices Company
Level of Experience : Senior Level
Employment Type : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT
Job Description
Key Responsibilities:
- Support US and EU regulatory submissions (exercising judgment to protect proprietary information).
- 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 product and process changes.
- Other incidental duties assigned by Leadership.
- 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