Job Description Summary

Job Description

Key responsibilities will include:

• Review and approve labels, labeling, and promotional materials to ensure regulatory compliance.

• Work closely with Marketing and project teams to develop, review, and substantiate product claims.

• Review protocols, reports, and journal articles to ensure collection of appropriate data to support promotional materials.

• Review label specifications for adherence to labeling procedure requirements.

• Collect and organize labeling related documentation for core team member review.

• Perform gap analysis to support labeling projects.

• Compile and categorize cross-functional feedback as an output to labeling review requests.

• Assist in regulatory activities related to US and OUS labeling remediation.

• Help draft and route SOP, work instructions, and policies to maintain compliance with applicable regulations and standards.

• Remain current on standards and regulations affecting advertising, promotion, and labeling and communicate the impact cross-functionally.

• Perform other duties and assignments as required.

About you:

To be successful in this role, you require:

• Excellent verbal and written communication skills.

• Proven ability to analyze, interpret, and review scientific, technical, and regulatory literature and documents while effectively communicating information to peers and management while working independently with minimum supervision.

• Excellent attention to details, and manages time efficiently.

• Flexible and adaptable to fulfill business priorities.

• Knowledge of global Regulatory Affairs requirements.

• Strong organizational skills

• Ability to represent Regulatory Affairs in multiple environments (i.e., Marketing, R&D, etc.) and work with all levels of management.

• Identify and communicate risks and mitigations associated with regulatory strategies to cross-functional collaborators.

Education and experience required:

• Bachelor’s degree in Life Sciences or Engineering. RAPS RAC an asset.

• At least three (3) years of Regulatory Affairs experience within the medical device and/or pharmaceutical industry.

• Familiarity and background with advertising, promotion, and labeling in the medical device industry.

• Proficient with MS Office tools (Word, Excel, PowerPoint, Outlook), and SAP.

Click on Apply if this sounds like you!

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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.