Grifols Shared Services North America, Inc Regulatory Affairs Specialist in San Diego, California
Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.
The Regulatory Affairs Specialist 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
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).
■ Review of product labeling, literature and Web site for accuracy, consistency and regulatory compliance.
Bachelor's Degree required in the life sciences or engineering with a minimum of 3-5 years direct experience in Regulatory Affairs within an IVD or Drug/Biologics Industry. Master’s Degree and/or RAC preferred with a minimum of 1-3 years direct experience in Regulatory Affairs within an IVD or Drug/Biologics Industry.
Demonstrated ability to coordinate complex projects. Strong oral and written communication and presentation skills.
Solid working knowledge of the US Regulations and European IVD and medical device directives
Good analytical and problem solving skills.
Demonstrate in-depth understanding of advanced technical/scientific principles related to IVD reagent chemistry, laboratory automation, and software components of IVD medical devices. Experience with (US) Biologics and IVDs highly desirable.
Capacity to communicate regulations to technical functions within the company.
Ability to manage relationships with FDA and international customers (e.g., regulatory agencies, distributors, etc.)Solid computer skills in Microsoft Office.
- 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: 458587