BD (Becton, Dickinson and Company) Jobs

Job Information

BD (Becton, Dickinson and Company) Regulatory Affairs Specialist in Salt Lake City, Utah

Job Description Summary

Working within the Regulatory Affairs (RA) organization, the Regulatory Affairs Specialist is responsible for the management of cross-functional activities to support European MDR remediation for BD’s Vascular Access Devices business group. This associate will be subject matter expert for assigned Summaries of Technical Documentation (STEDs) including the preparation, drafting, review, and submission to notified body. This role will support a cross-functional team tasked with the completion of STEDs and Procedure Pack Files.

Job Description

Responsibilities

·Prepare, draft, review, and submit Summaries of Technical Documentation (STEDs) to notified body

·Assess proposed device modifications for submission to notified body and/or prepare robust non-substantial change justifications for changes that do not require submission.

·Solicit input and feedback from supporting functions (R&D, Quality, Manufacturing, Medical Affairs, etc.).

·Represent RA and demonstrate leadership in complex product teams by identifying and interpreting relevant regulatory requirements and providing actionable regulatory guidance throughout the product development cycle prior to regulatory submission.

·Identify and communicate appropriately quantified risks and mitigation approaches associated with regulatory strategies to stakeholders.

·Support development and execution of global regulatory strategies by collaborating closely with international regulatory associates to register our devices worldwide.

·Lead regulatory efforts required to comply with new regulations (e.g., EU MDR/IVDR, MDSAP) and other requirements including changes to international standards.

·Review and approve product labeling, promotional materials, and advertising materials to ensure regulatory compliance.

·Review technical supporting protocols/reports to assure collection of appropriate data for regulatory submissions and regulatory compliance.

·Develop and maintain standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards.

·Coordinate and respond to requests for product information, and questionnaires requested by customers.

·Represent BD in relevant external trade organizations and regulatory standards development as necessary to support BD’s continuous product development and compliance efforts.

·Remain current on regulations affecting BD products (EU MDR/IVDR, reclassification activities, etc.) and keep the relevant team and supervisors informed about potential impact.

·Identify ways to improve the efficiency of current work process and execute them.

·Carry out the above tasks with limited supervision.

Requirements:

·B.S. degree with preference given to technical discipline (e.g., engineering, bioengineering, biology, chemistry, etc.) or related degree.

·Minimum 3 years experience in medical device or in vitro diagnostic device companies. Preference in Regulatory Affairs.

·Demonstrated ability to resolve problems and to make appropriate regulatory decisions under pressure.

·Demonstrated success in the preparation and completion of regulatory submissions (510(k), STED, technical file, etc.) to global regulatory agencies.

·Experience in negotiating with regulatory authority personnel (e.g. FDA, Notified Bodies) in medical device and in vitro diagnostic areas.

·Ability to work effectively in a virtual environment.

Preferred:

· International product registration experience

· Experience with virtual manufacturers and clinical evaluations is preferred.

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.

#LI-PRO

Primary Work Location

USA UT - Salt Lake City BAS

Additional Locations

Work Shift

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.

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

DirectEmployers