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). The Regulatory Affairs Associate II will also serve as regulatory affairs subject matter expert in design and development teams.
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).
● Support various design and development team meetings to serve as regulatory affairs subject matter expert in areas of labeling, verification & validation, design control, and product registrations.
● Review and approve advertising and promotional materials.
Prepare meeting agenda and minutes; Draft and finalize status reports and project highlights; Update submissions and approvals spreadsheets; Prepare Power Point presentations.
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.
Minimum 2 years life science, healthcare or diagnostics industry experience
Minimum 2 years of experience in regulatory affairs.
Experience working in a regulated environment
Experience in preparation of STED (standard technical documentation)
Excellent team player
Experience in design control process - i.e. product development; Knowledge of advertising and promotion regulations for healthcare products
May require traveling (10-15%).
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: 213409