Job Description Summary

As Senior Manager of Regulatory Affairs Systems and Operations, you will be responsible for overseeing the development, implementation, and maintenance of the global BDX Regulatory Information platform. The ideal candidate will oversee the regulatory information management (RIM) module, ensuring smooth and effective regulatory operations.

Associates are required to report to our Franklin Lakes, NJ headquarters 4 days a week.

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. 

Primary Responsibilities:

Sustaining System Support

• Acts as Global Process Owner for the BDX Regulatory Information Management solution and collaborates with functional leads and colleagues to evolve the operational module based RA community user needs, and overall, RA strategy.

• Leads the requirement identification, design, implementation, and continuous improvement of the BDX Regulatory Information Management solution from a regulatory affairs business lens.

• Collaborates with Regulatory Affairs Business Partners, Information Technology, and other functional partners to develop and execute against a functional technology roadmap.

• Manages vendor relationships.

Quality Management System Maintenance

• Authors/Reviews/Approves business application documentation. (e.g., SOPs, Global Technical Standards)

• Establishes training strategy and provides end-user support.

SDLC (Software Development Life Cycle) Support

• Leads application validation requirements pertaining to the business scope and strategy. i.e. Use Case Definition, Demo Feedback, Performance Qualification and Training Communication.  

• Approves and reviews SDLC documents and participates in key workshops; ensure user requirements, business process and design are understood/ aligned.

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Education and Experience:

• Minimum bachelor’s degree in science, engineering, or technology discipline required.

• Minimum 3 years of experience in business operations management (budget/resource planning, technology management, business case development, talent development, etc.)

• Minimum 2 years of experience supporting systems for a Regulatory Affairs function.

• Must have knowledge of FDA and other notified body regulations.

• Ability to travel US and OUS travel ~25-40%

• Prior experience with a Regulatory Affairs Information Management System platform(s) is required

• Prior experience working in an IT function with Computer Systems Validation (CSV) experience required

• Knowledge of medical device product life cycle process is required

• Prior experience in executing medical device registrations is desirable

• Proficient in English, both verbally and written

• Promotes a culture of teamwork, continuous improvement mindset, and drives accountability

• Ability to influence through effective communication, people management, and leadership skills.

• Critical competencies include leadership, financial and business acumen, dealing with ambiguity, organizational agility, and strategic thinking

• Recognized externally as active in improving the industry; proactive in external standards boards, industry groups, and policy working teams

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Comp