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Sr. Regulatory Affairs Specialist

Apply Now Job ID R-352411 Date posted 11/08/2019

Locations

San Jose, California

Job Description Summary

Job Description

The Sr. Regulatory Affairs Specialist will be responsible for the preparation of regulatory submissions in accordance with EU IVDR and for related activities such as development of new procedures, performance evaluation plan and report and training functional team members on the new requirements. This position requires candidate to collaborate with other functions (R&D, Quality, Operations) and external consultants. Experience in project management is preferred.

Job responsibilities:

  • Understand and interpret EU in vitro diagnostic device (IVD) regulatory requirements.

  • Draft and prepare product technical files compliant to EU IVDR.

  • Coordinate and project manage the preparation of technical files by external consultants.

  • Represent RA in IVDR core team and identify regulatory activities for project schedule.

  • Interface with Notified body to obtain approval of Technical Files.

  • Coordinate the preparation of additional data/information requested by notified body and prepares appropriate responses to all such requests.

  • Responsible for writing and updating standard operating procedures (SOP) and work instructions (WI) to support the implementation of IVDR.

  • Conduct training on IVDR requirements, new SOP’s and WI’s.

  • Participate in the development and review of performance evaluation plan and report.

  • Review analytical protocols and clinical protocols to assure collection of appropriate data for regulatory submissions.

  • Review labels, labeling, and promotional materials for compliance with IVDR.

  • Provide regulatory opinions on EU IVDR regulatory requirements, export, and labeling requirements.

Minimum Qualifications:​

Education and Experience:

  • Minimum of a Bachelor's Degree in life sciences or engineering.

  • Minimum of 5 years’ experience in regulatory affairs supporting device/diagnostic industry (IVDR/MDR).

  • Minimum of 3 years' experience authoring Tech files and interfacing with Notified Bodies to obtain approval. 

  • 510(k) submission experience is strongly preferred.

  • Demonstrated ability to project manage regulatory submissions.

  • Demonstrated ability to interpret and implement new regulations.

  • Working knowledge of EU in vitro diagnostic or medical device regulatory requirements and 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.

#LI-TECH

Primary Work Location

USA CA - San Jose

Additional Locations

Work Shift

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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.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com