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Sr. Regulatory Affairs Specialist

Organization
BD Life Sciences
Job Location
2350 Qume Drive
San Jose, CA 95131
United States
Salary
DOE
Job Description


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 (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.

 

Job responsibilities:

  • Negotiate and establish product submission priorities that 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

Requirements


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.

 

Job responsibilities:

  • Negotiate and establish product submission priorities that 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

 

Minimum Qualifications:

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

How to Apply
About Our Organization

BD is a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. BD leads in patient and healthcare worker safety and the technologies that enable medical research and clinical laboratories. The company provides innovative solutions that help advance medical research and genomics, enhance the diagnosis of infectious disease and cancer, improve medication management, promote infection prevention, equip surgical and interventional procedures and support the management of diabetes.