Grifols Shared Services North America, Inc Regulatory Affairs Associate II in Emeryville, California
The Regulatory Affairs Associate I will be responsible for preparing technical files and international product master files (e.g. STED), to support global regulatory submissions for the registration of IVD systems (assays, instruments, software).
Primary responsibilities for role:
Prepare regulatory submissions for applicable foreign regulatory bodies, such as EU Technical Files and STED (and their local equivalents), for registration of in vitro diagnostic and/or biological products.
Coordinate and prepare responses to deficiency letters or requests for additional information from competent authorities
Interface collaboratively with partners and local liaisons for management of submissions in foreign countries.
Prepare technical, quality, manufacturing, and regulatory data and documentation for the purpose of developing foreign regulatory submissions.
Support other regulatory activities, as assigned (e.g. document filing; labeling review; import/export issues; regulatory intelligence).
Prepare meeting agenda and minutes; Draft and finalize status reports and project highlights; Update submissions and approvals spreadsheets.
Knowledge, Skills, and Abilities:
Excellent command of the English language (oral or written). Knowledge of a second foreign language is preferred. Proficiency in Microsoft Office and Adobe Acrobat.
Bachelor of Science and/or graduate degree in the Life Sciences. Experience in regulatory affairs may substitute for this educational requirement.
Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.
- May occasionally lift, carry, push, pull or otherwise manipulate objects up to 25 pounds in weight, and/or lift, carry, push, pull or otherwise manipulate objects up to 10 pounds in weight frequently or continuously. EEO Minorities/ Disability/Veterans Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws. We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.
Req ID: 226069