Sunrise Systems, Inc. · 3 months ago
Regulatory Affairs Specialists III
Beachwood, OH
Full-time
Onsite
Mid Level
4+ years expSunrise Systems, Inc. is seeking an experienced Regulatory Affairs Specialist to support product development, regulatory submissions, and compliance for global markets. The role involves developing regulatory strategies, preparing submissions, and ensuring compliance with regulations.
Information Technology & Services
Responsibilities
Develop and execute regulatory strategies for new and existing products
Prepare and submit 510(k)s, EU MDR files, and global regulatory submissions (NMPA, TGA, etc.)
Review product changes, advertising, and promotional materials for compliance
Support audits, inspections, and post-market activities
Qualification
Required
Bachelor's degree in Science, Engineering, or related field
4+ years' experience in Regulatory Affairs within a regulated industry (medical devices preferred)
Strong communication and project management skills
Proficiency in MS Office
Preferred
RAC certification a plus
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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