Cynet Systems · 1 month ago
Senior Regulatory Affairs Specialist - Remote / Telecommute
United States
Full-time
Remote
Senior Level
$60/hr - $64/hr
5+ years expCynet Systems is a company focused on regulatory affairs, seeking a Senior Regulatory Affairs Specialist. The role involves assessing regulatory impact, developing strategies, and providing guidance on registration requirements for medical devices.
EmploymentRecruitingStaffing Agency
Responsibilities
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
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
Cynet Systems
Headquartered in Washington DC Metro Area, Cynet Systems is a top talent supplier for companies across North America.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Ashwani (Ash) M.
Partner and Co-CEO
Nikhil "Nick" Budhiraja
Founder / Co-CEO
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