Job Description Summary

Job Description

About the role:

As the Staff Specialist, Regulatory Affairs, you will provide regulatory support to the Medication Management Solutions (MMS) Regulatory Affairs team and contribute to the success of the RA 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). You will help manage, collect, store and maintain all documentation related to RA. This role will become a super-user for the Regulatory Information Management (RIM) System and the SAP system, etc.

This remote position in Canada must either be in the Pacific region, or must be able to work on Pacific timezone if in another region.

Key responsibilities will include:

• 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.).

• Support Life Cycle Management project portfolios for Infusion.

• 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.

About you:

To be successful in this role, you require

• Strong organizational skills and good prioritizing, interpersonal, communication, analytical skills and ability to multi-task disparate projects.

• Represent Regulatory Affairs within a cross-functional setting 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.

• Excellent interpersonal, communication and analytical skills.

Education and experience required:

• Bachelors Degree in Life Sciences, preferably Masters Degree.

• Minimum of four (4) years of Regulatory Affairs experience in the medical device industry with working knowledge of UDI.

• Regulatory Information Management “system”, SAP or other systems experience, preferred

Click on Apply if this sounds like you!

Primary Work Location

CAN Mississauga - Derry Road West

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.