BD (Becton, Dickinson and Company) Jobs

Job Information

BD (Becton, Dickinson and Company) International RA Specialist (Remote Optional) in Warwick, Rhode Island

Job Description Summary

This position will be working in the BD Interventional Surgery Business Unit on implantable and absorbable devices. Under the guidance of a Staff Regulatory Affairs Specialist, 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.

Job Description

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.

  • Coordinate and prepare technical files for submissions to notified bodies for timely CE marking of new and modified products, with appropriate input from supporting functions (R&D, Quality, Manufacturing, etc.).

  • Assist in the review and approval product labeling, promotional, and advertising materials to ensure regulatory compliance.

  • 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

  • B.S. or equivalent with emphasis on material science or mechanical engineering. (Professional certifications preferred).

  • 1-3 years working in Regulatory Affairs

  • 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

  • Proficient oral and written communications skills - analytical thinking and technical writing; ability to work on cross-functional teams; ability to manage several parallel deliverables.

  • Working knowledge of statistics and 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

Key Relationships

Internal Relationships: Regional Business Regulatory Personnel, other BDI Surgery functional groups such as Quality Assurance, Research and Development, Sales, Marketing, Field Assurance, Sterilization, Supply Chain

External Relationships: OEM contacts, BDI Surgery Customer Support, Distributors and various vendors

Why join us?

A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.

To learn more about BD visit https://jobs.bd.com/

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 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.

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