Job Description Summary

The Senior Manager of Regulatory Affairs will lead a group of high performing individuals focused on infusion pump new product development and sustaining projects.

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. 

Summary of Job Responsibilities

The Senior Manager of Regulatory Affairs will provide regulatory support for infusion medical device products . The role includes but is not limited to the development and implementation of regulatory strategies for new product submissions, handling existing product registrations including variations and renewals, interacting with global internal stakeholders as well as external consultants/service providers in support of registration activities, developing and maintaining documentation for compliance programs such as labeling, promotional material review, and other regulatory requirements.  

Key Accountabilities

• Lead existing registrations by preparing and filing variation and renewal applications for approvals or extensions of approvals in various countries around the world.  

• Provide oversight and guidance to external service providers supporting registration activities.  

• Work closely with cross-functional teams on submission strategy and documentation development for new product submissions

• Coordinate interactions between internal stakeholders and external service providers to ensure timely completion of registration milestones.  

• Assist in the maintenance of departmental systems used to track product registrations and compliance programs.  

• Directly contact regulators on behalf of the organization during inspections and/or meetings.  

• Perform additional tasks as required.

Education

• Bachelor’s degree in Science, Engineering, Business Administration or equivalent.  

• Advanced degree (Master’s degree or higher) preferred.  

Experience

• Minimum 10 years of relevant work experience, preferably within the Medical Device industry.  

• Experience working with external service providers, consultants, and regulators required.  

• Prior experience in Regulatory Affairs with a focus on International Markets preferred.  

• Knowledge of medical devices and their regulation strongly preferred.  

• Familiarity with Infusion Pumps preferred.  

• Ability to travel up to 10% domestically and internationally may be required.

Skills & Competencies

• Strong project management skills and organizational abilities.  

• Excellent written and verbal communication skills.  

• Proficiency in Microsoft Office Suite, especially Excel and PowerPoint.  

• Proven ability to handle multiple priorities simultaneously while meeting deadlines.  

• Demonstrated interpersonal skills necessary to optimally collaborate across departments and geographies.  

• Proactive approach to problem solving with strong attention to detail.  

• Team player who takes initiative.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.  

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the futu