BD (Becton, Dickinson and Company) Sr. Regulatory Affairs Specialist in San Jose, California
Job Description Summary
The Sr. Regulatory Affairs Specialist will be responsible for the preparation and approval of regulatory submissions required to market new or modified in vitro diagnostic devices (IVD) in international markets or research use only (RUO) products globally. This responsibility entails development, execution and management of procedures and systems designed to ensure that the product development process addresses all regulatory requirements as well as the objectives of the business.
Negotiate and establish productsubmission prioritiesthat are aligned with region/country need; BDB integrated Regulatory Affairs Operating Plan (iRAOP) and Annual Strategic Review (ASR) plans
Support product registrations in assigned regions; monitor and track progress.
Manage and coordinate the electronic Global Product Submission (eGPS) database to ensure up-to-date, reliable source documents for product registrations are stored, linked, scanned and uploaded into the database.
Respond and track the additional information requests (AIRs) submitted by International Regulatory partners.
Conduct surveys to understand regulatory requirements and develop regulatory strategy for new products
Develop and maintain procedures and/or work instructions for product registrations.
Coordinate and collect specific registration information with R&D, Marketing, QA, Medical and other applicable departments as necessary.
Interface with OEMs to collect specific registration information.
Interface with applicable regulatory agencies and international consulates.
Submit and maintain laser registrations for all instruments (IVD and RUO)
Prepare Technical files and DoC to support product launches
Represent RA in platform core teams as needed
Education and Experience:
Bachelor's Degree required, preferrably in the biological sciences, chemistry or related science.
Minimum 3 years’ experience in the device/diagnostic, biologic and/or pharmaceutical industry, preferably in the area of regulatory affairs.
Ideal candidate will have demonstrated ability to interpret new regulations, and understand and interpret international regulatory requirements for in vitro diagnostic device (IVD).
Current knowledge of Good Laboratory Practices (GLP) and Quality System Regulations (QSR); Laser product registrations; Machinery Directive and European quality system standards.
Ability to effectively communicate both verbally and in writing to all levels within the organization and external to the organization.
Ability to prioritize, multi task, and organize work; project management experience desirable
Additional activities as needed to support RA goals
Primary Work LocationUSA CA - San Jose
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.