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Specialist, Regulatory Affairs, Data - REMOTE

Becton Dickinson

Becton Dickinson

Kuala Lumpur, Malaysia
Posted on Tuesday, April 23, 2024

Job Description Summary

Job Description

We are the makers of possible

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Why Join Us?

A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.

Become a maker of possible with us!

The Specialist, Regulatory Affairs, Data provides regulatory support to the Medication Management Solutions (MMS) Regulatory Affairs team and contributes to the success of the

Role Summary:

Regulatory Affairs department by leading data and regulatory requirements for UDI (Unique Device Identifier) and assisting with other data initiatives for MMS, such as PIM and DMS (Document Management System). This role will help manage, collect, store and maintain all documentation related to Regulatory Affairs. This role will become a super-user for the Regulatory Information Management (RIM) System and the SAP system, etc.

This role is a remote position.

In this role you will be responsible for:

  • Leads efforts for UDI for MMS RA addressing US, EU, and International requirements, staying abreast to the changing global requirements for UDI.
  • Functions as a super-user on RA systems and assists in managing the data structure of the RA network (PIM, DMS, etc.).
  • Collects, stores, and maintains all RA documentation, including correspondence and approvals.
  • Assists in preparing, auditing, editing, and publishing registration documentation, as needed.
  • Assists with managing the data structure of the RA network.
  • Acts as a liaison between the RA team and IT; helps provide a standardized desktop for the RA team.
  • Assists with submitting CFG applications and fee payments to the FDA, other requests where needed.
  • Identify ways to improve the efficiency of current work process and execute them.
  • Performs other duties and assignments as required.

To be successful in this role, you require:

  • Knowledge of global regulatory affairs requirements (UDI, etc.).
  • Strong organizational skills.
  • Good prioritizing, interpersonal, communication, analytical skills and ability to multi-task disparate projects.
  • Represent Regulatory Affairs in multiple environments (i.e., Marketing, R&D, etc.) and work with all levels of management.
  • Read, analyze, and interpret regulatory literature and documents while effectively communicating information to peers and management while working independently with minimum supervision.
  • Define problems, collect data, establish facts, make decisions, solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
  • Present complex information to cross-functional groups in clear and concise manner.

Education and experience required:

  • Bachelors Degree, preferably Masters Degree in life sciences.
  • Minimum of 4-6 years of Regulatory Affairs experience in medical device company, with working knowledge of UDI.
  • Regulatory Information Management “system”, SAP or other systems experience, preferred
  • Excellent interpersonal, communication and analytical skills.

Click on apply if this sounds like you!

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.

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

Primary Work Location

MYS Kuala Lumpur - Jalan Kerinchi

Additional Locations

Work Shift