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.
...innovation, we have established ourselves as a trusted partner in the industry. Our team is looking for a highly skilled call center customer service manager who can motivate sales and service supervisors to achieve department goals and champion their teams to deliver...
...General Sales Manager - Automotive Our company has an outstanding opportunity for a results-focused, highly driven and experienced General Sales Manager who would be responsible for the dealerships sales objectives, goals, and overall customer satisfaction at the...
...and receiving) and perform physical inventory counts in the Distribution Center. Demonstrate the company's core values of respect, honesty,... ...Based in Portland, Oregon, Fred Meyer merged with The Kroger Company in 1998. Today, we're proudly serving Fred Meyer customers...
...Data Entry Specialist Our organization is looking for a Data Entry Specialist with superior attention to detail and the ability to maintain... ...typing skills (minimum 40 wpm recommended) Proficient in MS Excel and database applications High degree of accuracy and...
...support for the park. Responsibilities: Specific Duties and Responsibilities: General Carpentry: This requires construction, demolition, repair, and remodeling park facilities and attractions. This requires the use of typical carpentry tools, lifting and carrying...