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. 

Functional/Organizational Summary

This position will be working in BD-Connected Care on Regulatory Affairs projects that support the Pharmacy Automation business. This role will carry out related regulatory affairs activities, such as development, execution and management of submissions, development and review of procedures and systems designed to support the regulatoryprocesses, and address global regulatory requirements as well as theobjectives of the business. 

Position Summary  

This position is responsible for support of a variety of regulatory activities and projects, and/or personnel.  The primary focus of this position is to assess and communicate the impact of new and changing regulatory requirements and standards.  The role may also be responsible forassessing changes to commercialized product to determine the worldwide regulatory impact of the change, preparing documentation to support the regulatory pathway for the change, and communicating the change impact to affected organizations across BD.  This position may provide Regulatory guidance to project teams, Operations, and/or Sales in relation to the changes.  This position requires staying abreast of global regulations to help Pharmacy Automation achieve its business goals within the scope of this position, contributes to regulatory affairs strategy development, and exhibits strong cross functional influencing skills.

Key responsibilities:

• Assess and communicate the impact of new and changing regulatory requirements and standards.

• Develop and execute comprehensive product strategies, roadmaps, and business cases for assigned product lines, aligning with overall business objectives.

• Review, approve, and document regulatory changes to commercialized devices.   

• Identify and communicate appropriately quantified risks and mitigation strategies associated with regulatory changes to partners.

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

• Review changes and related documentation to assure collection of appropriate data for regulatory submissions and regulatory compliance.

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

• Work cross-functionally across multiple departments to communicate change impact. 

• Remain current on standards and regulations affecting BD products and communicate and incorporate required changes.

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

• Performs other duties and assignments as required.

Professional Skills & Key Competencies:

• Read, analyze, and interpret new and changing regulatory requirements and standards(e.g., Electrical and Electromagnetic Equipment, Machinery, Data and Cybersecurity, Board of Pharmacy, Environmental)

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

• Effectively 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.

• Solve 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. 

• May supervise professional level staff.

Minimum Requirements:

• Bachelor's degree
• Minimum 5 years of strong Regulatory Affairs experience in the medical device and/or in vitro diagnostic and/or regulated product field
• Project Management experience
• Sound understanding of design control processes, FDA, and global regulations and standards
• Ability to manage multiple projects, meet deadlines, and prioritize/organize complex information
• Excellent interpersonal, communication and analytical skills
• Knowledge of software and instrument design regulations and standards

Preferred Qualifications:

• Master's degree in life sciences field (preferred over Bachelor's)
• RAC certification (Regulatory Affairs Certification)
• PMP certification (Project Management Professional)
• Familiarity with Electrical and Electromagnetic Equipment, Machinery, Data and Cybersecurity, Board of Pharmacy, and Environmental requirements
• Working knowledge of medical device stand-alone software, device interoperability and IEC 62304 software development lifecycl