Job Details

International Regulatory Affairs Specialist REMOTE OPTIONAL

Company name
Becton, Dickinson and Company (BD)

Location
Warwick, RI, United States

Employment Type
Full-Time

Industry
Compliance

Posted on
Mar 05, 2021

Valid Through
Jun 18, 2021

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Job Description Summary

Job Description

This position will be working in the BD Interventional Surgery Business Unit on implantable hernia mesh products and fixation devices. Under the guidance of the Associate Director of Regulatory Affairs, the position will provide technical and administrative regulatory support to ensure timely introduction of new products subject to medical device regulations in U.S. and global regions, with a focus on strategic global expansion of our portfolio. Additionally, the position will provide regulatory support to marketed products and ensure company's regulatory compliance status.

Responsibilities:

Collaborate and strategize with Platform RA Global Strategy Lead and International Marketing team to drive global expansion of portfolio.

Provide the global regulatory expertise for new product development teams and for significant design changes to existing products

Liaison with regional RA colleagues and Platform RA, to provide accurate country specific regulatory assessments and approval timelines.

Informing the Platform Core team on new and changing country specific regulations and requirements.

Providing metrics as needed for global expansion reporting

Assess necessity for reporting changes to FDA for proposed device modifications.

Prepare robust reporting justifications for changes that do not require supplements or notices.

Assist Product Development and Quality Assurance in planning testing that will ultimately be used in regulatory submissions.

Assist in updates to 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.

Remains current on regulations affecting BD products and keep the relevant team and supervisors informed about potential impact.

Qualifications

Bachelor’s degree required

1-2 years of regulatory affairs experience

Knowledge and experience with regulatory requirements for medical devices (IDE’s, PMA’s ,510(k)’s, CE mark technical files and design dossiers).

Global Regulatory Experience

Working knowledge of electronic documentation and information systems.

Ability and desire to travel as needed.

Desire to learn and grow in a fast-paced medical device company

Knowledge, Skills, and Abilities:

Proficient in using Microsoft Word, Excel, PowerPoint, and Project.

Ability to handle multiple tasks with attention to detail and limited supervision.

Demonstrates global perspective, customer focus, cross-functional collaboration, and teamwork skills.

Excellent communication and collaboration skills with internal and external stakeholders

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 LocationUSA RI - Warwick

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.

Company info

Becton, Dickinson and Company (BD)
Website : http://www.bd.com/

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