Sr. International Regulatory Affairs Specialist

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Location :
San Jose, California

Expiry Date :
Mon, 08 Mar 2021 23:59:59 GMT

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Description :
Job Description Summary Job Description 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 in EU and other international markets. 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. Job responsibilities: – Understands and interprets EU and International in vitro diagnostic device (IVD) regulatory requirements. – Provides guidance on requirements to product development teams. – Performs gap analysis of existing Technical Files against local regulatory requirements (country-specific), and represents RA in cross-functional teams tasked to fill the gaps. – Develops strategies for submissions to International Regulatory Agencies. – Prepares and/or compiles information required by international regulatory associates to register or license products outside the EU. – Coordinates the preparation of additional data/information requested by notified body/ regulatory agencies and prepares appropriate responses to all such requests – Provides risk assessments and regulatory options. – Completes and updates Technical File necessary for new product approval and product continuance. – Interacts and negotiates with International Regulatory Agencies. – Participates in the development and review of Performance evaluation report. – Reviews Analytical and Clinical protocols to assure collection of appropriate data for regulatory submissions in collaboration with cross-functional stakeholders. – Reviews labels, labeling, and promotional materials for compliance with applicable regulations and policies. – Provides regulatory opinions on pre-market regulatory requirements, export, and labeling requirements. – Leads/ Support implementation of Regulatory Operations projects and maintenance of Regulatory Databases – Develop, review and/or update Regulatory procedures Minimum Qualifications: Education and Experience: – Minimum of a Bachelor’s degree required. Preferably in biological sciences, chemistry or related science. – Minimum 3 years experience in the device/diagnostic, biologic and/or pharmaceutical industry, preferably in the area of International Regulatory Affairs. – Tech file preparation and approval experience a plus. – Ideal candidate willhave proven ability to interpret new regulations, and understand and interpret EU (IVDR) and Global in vitro diagnostic device (IVD) regulatory requirements. – Current knowledge of EU medical device and in vitro diagnostic regulatory requirements, Good Laboratory Practices (GLP) and Quality System Regulations (QSR); 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. – Train and/ or supervise junior associates as needed. – Ability to work in a team environment, motivated, and fast-learner. BD and Covid-19: To ensure the safety of our associates, BD supports remote work where possible. This position is based in the listed location, but is temporarily remote-based due to Covid-19. Any offer of employment is contingent upon the candidate reporting to work at the site if/when associates are requested to return to the workplace. 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. #LI-PRO Primary Work LocationUSA CA – San Jose Additional Locations Work Shift