Job Description Summary

This role will assist in International registrations for BD's Infusion platform, with a focus on software.

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. 

 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

Job Overview

This position is responsible for support of a variety of international related regulatory activities and projects for complex infusion products containing software.  This position is responsible for developing and implementing strategies for worldwide governmental approval to introduce new products and maintain existing products to international geographies, providing mentorship and advice on international regulatory requirements, providing oversight to and preparation of worldwide submissions and negotiating their approval with the agencies. 

Key Responsibilities

• Represent international RA and demonstrate leadership in sophisticated product development strategies by identifying and interpreting relevant regulatory requirements, and providing actionable regulatory mentorship throughout the product development cycle prior to regulatory submission.

• Identify and communicate appropriately quantified risks and mitigation strategies associated with international regulatory strategies to collaborators.

• Proactively lead regulatory efforts required to align with new regulations and requirements; i.e., Canada, Latin America, EU MDR, MDSAP.

• Review protocols and reports to assure collection of appropriate data for global regulatory submissions and regulatory compliance.

• Write and update standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards.

• Prepare global strategies for changes to commercialized products.  Work cross-functionally and lead cross-functional teams to implement global updates.

• Remain current on standards and regulations affecting BD products and keep the relevant team and supervisors advised about potential impact.

• Identify ways to improve the efficiency of current work process and implement them.

• Performs other duties and assignments as required.

Professional Skills & Key Proficiencies

• Read, analyze, and interpret, and review scientific, technical, and regulatory literature and documents.

• Successfully communicate information to peers and all levels of management.

• Translate regulations and guidelines into terms that other functions can understand and apply.

• Define problems, collect data, establish facts, and draw valid conclusions; communicate the conclusions both verbally and in writing to a variety of audiences.

• Address practical problems based on a variety of concrete variables in situations where only limited standardization exists.

• Excellent writing skills; both formatting as well as the development of a clear logic trail to develop conclusions based on an understanding of factual evidence.

• Strong influencing skills. Establishes process and provides expertise for a specific area. 

Qualifications

• Bachelor’s degree required. Master’s degree in life sciences preferred.

• 5 years of Regulatory Affairs experience in the medical device industry preferred

• Applied knowledge of IEC 62304

• Sound understanding of design control processes, FDA, and global regulations and standards.

• Ability to prioritise multiple projects, meet deadlines, and prioritize/coordinate sophisticatedex information.

• Excellent interpersonal, communication and analytical skills.

Preferred Skills & Knowledge

• Familiarity with infusion pumps, safety assurance cases, and cybersecurity. 

For certain roles at BD, employment is contingent upon the Company’s