Cardinal Health Sr./Principal Regulatory Affairs Specialist in Milpitas, California
What Reg Affairs contributes to Cardinal Health
Develop regulatory submissions and assessments (in compliance with applicable regulations and standards) to ensure timely global commercialization of products.
- Bachelor’s degree in Engineering, Physical or Biological science + a minimum of 3 - 5 years’ experience in Regulatory, or advanced degree + 2 - 4 years’ experience in Regulatory.
- Bachelor’s degree in Engineering, Physical or Biological science + a minimum of 5 - 7 years’ experience in Regulatory, or advanced degree + 3 - 5 years’ experience in Regulatory.
What is expected of you and others at this level
- Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects
- May contribute to the development of policies and procedures
- Works on complex projects of large scope
- Develops technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectives
- Completes work independently receives general guidance on new projects
- Work reviewed for purpose of meeting objectives
- May act as a mentor to less experienced colleagues
Essential Duties & Responsibilities
- Manage & lead EU MDR project
- Develop and implement regulatory strategies and processes to ensure timely global commercialization of products in compliance with applicable regulations and standards.
- Author regulatory submissions and assessments for Class II and III medical devices to be distributed in the US and EU (CE Mark) to ensure timely global commercialization of products in compliance with applicable regulations and standards.
- Prepare international documentation to support product registration internationally.
- Directly communicate with US FDA and other regulatory agencies in preparing responses to submissions and in support of agency audits.
- Evaluate proposed changes to product design or manufacturing processes and assess impact of the proposed changes with regard to worldwide approvals and internal Cordis Corporation, or its parent company, Cardinal Health, policies and procedures.
- Participate on new product development teams.
- Review and approve new product development and product modification documentation.
- Write, review and revise company Quality System procedures as required.
- Communicate business related issues or opportunities to next management level.
- Ensure personal and company compliance with all Federal, State, local and company regulations, policies, and procedures.
- Responsible for communicating business related issues or opportunities to next management level
- For employees with supervisory responsibilities, ensure that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
- Responsible for ensuring compliance with Quality Procedures, Laws and Regulations of the applicable markets
Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.