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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.

Requirements:

• 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
• 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