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 Description About this role The Recruiter is responsible for sourcing and recruiting candidates to fill temporary, temporary-to-hire, and direct-hire job orders for a variety of moderately complex, complex, and specialized clients-partners with clients to define...
...Gynecologists to join an outstanding and growing OB/GYN program. This OBGYN group is part of a... ...a highly collaborative group of 6 OBGYN physicians with plans to expand MFM, REI and mid-... ...paid time off Excellent Relocation Assistance packages Note: Benefits may vary...
...days per week, including nights, weekends, and holidays is preferred Preferred Qualifications: Proficient in English and Japanese Language Knowledge of Hawaiian language preferred Previous work experience in a Hotel/Front Desk environment Previous experience...
...Job Description Hunter Recruiting is seeking a travel nurse RN Endoscopy for a travel nursing job in Warrensville Heights, Ohio. Job Description & Requirements ~ Specialty: Endoscopy ~ Discipline: RN ~ Start Date: 01/30/2026~ Duration: 13 weeks ~40 hours...
...Provide security and physical protection for service members Assist in crowd control and riot prevention Operate military prisons (brigs) aboard ships and on shore Handle and care and training for dogs that detect narcotics and explosives Provide protective...