Sr. Regulatory Affairs Specialist Locations: Sunnyvale, CA Job Type: On-site, FTE Salary Range: 80K-140K Responsibilities: In this role, you will be part of the regulatory team responsible for proper oversight of medical device development and market introduction. You will work closely with Quality, Engineering, Product Management, Marketing, and Sales teams to perform regulatory pre- and post-market analysis and implement and maintain an ISO 13485 and FDA-compliant Quality Management System. Participate in the preparation and review of regulatory submissions to the US FDA and international (outside the US) regulatory authorities. Support government interactions pertaining to medical device registrations and licensing. Participate in the development of regional regulatory strategy and update strategy based on regulatory changes. FDA 510k and EUA application. Provide regulatory support to cross-functional product development and project teams throughout the product lifecycle. Support regulatory activities required for MDR compliance. Provide regulatory assessment for manufacturing and design changes. Provide regulatory review and approval of change order packets. Support product regulatory intelligence and risk assessments. Assist in maintaining compliance with product post-market requirements. Support post-market regulatory actions taken for the products. Assist in the review of advertising and promotional materials. Support internal and external audits. Ensure compliance with internal procedures and external regulations and standards. Maintain and update quality system procedures. Maintain quality records and other controlled documents. Other Regulatory and Quality duties as assigned. Requirements: Bachelor’s degree in Science, Engineering, Math, a medical field, or an equivalent educational background with a focus on technical writing, scientific methodologies, and problem-solving. A minimum of 5 years of experience in medical device Regulatory Affairs, showcasing a comprehensive understanding of regulatory frameworks. Demonstrated ability to manage small projects, displaying exceptional organization, independence, and outcome-driven focus. Outstanding analytical and communication skills, paired with a strong sense of teamwork and meticulous attention to detail. #J-18808-Ljbffr Ipro Networks Pte. Ltd.
...Job Summary: Ideal candidates approach their job with pride, cook from their hearts, and genuinely love to take care of their guests. Previous experience with fresh seasonal ingredients, butchery, appreciated but not necessary. Uncompromising work ethic and attention...
...Drywall/Texture/Paint PuroClean is an established and growing insurance contractor providing remodel and repair services for water and fire damaged properties. We are interviewing for immediate hire an individual with expert skills in drywall/texture/paint. The company...
...Job Description Are you ready to lead transformative projects that directly impact patient care and healthcare delivery? Our client is seeking a Senior IT Project Manager with expertise in Epic Clinical Applications to drive strategic initiatives across a leading...
...with a leading healthcare organization is looking for a Senior Project Manager to support complex, clinically focused healthcare IT... ...ladder and plays a critical role in delivering high-visibility Epic and non-Epic projects across hospitals, clinics, and inpatient...
...Description Job Description Located in Grand Forks, ND Salary: $19 Express Employment is seeking a detail-oriented and organized Inventory & Accounting Coordinator to support our operations. This role is key to keeping production, inventory, and accounting processes...