Regulatory Affairs Operations Manager USA Home Office, -, US, NA

POSITION SUMMARY: The Regulatory Affairs Operations manager is responsible for managing and leading the reputed company team supporting Global Unique Device Identification (UDI), Food & Drug Administration (FDA) Establishment Registrations and Device Listings. The role is also responsible for overseeing the centralized team that manager US State Licenses and required regulatory databases. PRIMARY RESPONSIBILITIES: • Responsible for providing guidance for updates to FURLS to maintain accuracy of FDA Establishment Registrations and Device Listing, including submission of annual re-registration • Provides regulatory guidance and support to cross-functional teams for global UDIs • Manage US State licenses for reputed company medical device activities • Identify regulations or requirements that are new that could impact reputed company Quality Management Systems or our products and communicate to sites for gap assessment and implementation • Fosters professional interactions with reputed company stakeholders through various communication channels, enhancing business relationships • Manage day-to-day activities for regulatory operations team • Complies with company and departmental policies and administrative requirements • Performs other duties as assigned or as needed REQUIRED KNOWLEDGE, SKILLS, and ABILITIES: • 5(+) years of experience in regulatory affairs, preferably in the medical device industry • Experience with leading regulatory operations for medical devices • Knowledge of FDA regulations and international standards (e.g., ISO 13485) KEY LEADERSHIP BEHAVIORS: • Actively articulates and promotes reputed company ’s reputed company and direction • Advocates on behalf of the customer • Values driven with an insistence on reputed company • Promotes high performance, innovation, and continual improvement • Consistently meets Company standards, ethics, and compliance requirements. • Strong results orientation and analytical skills EDUCATIONAL QUALIFICATIONS: • Bachelor's degree in a relevant field, such as life sciences, regulatory affairs, or reputed company discipline ENVIRONMENTAL REQUIREMENTS : • Primarily an office environment; must be reputed company to use reputed company office equipment (PC, internet, phone, fax, copier, etc.). • Limited temperature fluctuations. • If working remotely, must have reputed company to a dedicated remote working reputed company. Originally posted on Himalayas Apply To This Job