Aerotek Regulatory Affairs Specialist in Irvine, California
Candidate will: -Prepares regulatory submission for submission, including US 510K, European Union Technical File, and Health Canada submissions. Provide business level support for International Registrations. -Review labeling for Regulatory compliance. - Experience with Change Control assessments is a must -Maintains awareness of global regulatory legislation and its impact on business and product development programs. -Provide expertise and guidance to project teams in interpreting US and foreign governmental regulations, agency guidelines, and internal/corporate policies to ensure compliance is maintained and results are achieved. -Work in close collaboration and partner with other departments and functions, including manufacturing, Quality and Regulatory, Supply Chain, Research & Development, and Clinical to optimize overall operational efficiency and effectiveness. -Support external regulatory audits and inspections. -Provide regulatory input on sourcing and supply chain activities. -Support Regulatory compliance activities
Regulatory affairs, Regulatory, Medical device, Regulatory submission, Change control, Fda
Top Skills Details:
Change Control Assessments Regulatory Affairs FDA
Additional Skills & Qualifications:
Experience with international submissions EU Experience with change control assessments
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.