Job Description Summary

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.

The Director, Regulatory Affairs will be a member of the Peripheral Intravenous Catheter (PIVC) platform leadership team.  They will be responsible for directing all regulatory affairs activities for the PIVC platform to ensure global product registration and compliance objectives are met.  They must be able to collaborate effectively with R&D, Marketing, and other functional areas to provide expertise in the development of global regulatory strategies to obtain clearance/approval of the PIVC platform’s products in global markets.

Responsibilities:

• Coordinates the global activities of the entire PIVC Regulatory Affairs (RA) staff
• Works with platform and functional management as required to establish and periodically measure PIVC RA department goals and objectives which are consistent with overall Business Unit and Corporate Driver Goals
• Works with both domestic and international counterparts in the development of global regulatory strategies and plans
• Manages fiscal responsibilities for the department by planning and preparing an annual operating budget, and monitoring revenues and expenditures throughout the budget cycle
• Assesses priorities and makes resource assignments to team members to assure project and platform priorities are met
• Complies with corporate and divisional procedures and policies, and government regulations
• Keeps abreast of new methods and developments in the regulatory field and effects appropriate modifications to procedures where appropriate
• Provides timely information to platform and functional management on issues which will affect the PIVC platform’s performance
• Assures US and International submission activities are completed in an organized and timely manner
• Directs the preparation of US, EU, and other global regulatory submissions, providing critical input where needed to ensure successful clearance/approval is achieved
• Presents PIVC RA department issues, progress reports, etc. to both platform and functional management, as required
• Motivates and develops regulatory team members
• Directs ongoing CE Marking activities, including required technical file/dossier updates
• Interacts with regulatory agencies to ensure a smooth working relationship
• Leads and/or supports FDA, Notified Body, and other audits/inspections

Qualifications:

• Bachelor's degree or higher, preferably in a scientific discipline
• Master's degree in Regulatory Affairs preferred
• Regulatory Affairs Certification (RAC) preferred
• 10+ years of progressively more responsible experience as a multi-functional Regulatory Affairs professional in the medical device industry
• 10+ years’ experience managing people and multiple product line(s) and/or programs
• Experience working in a multi-level corporate environment typical of large corporations
• Experience leading communications with FDA, EU notified bodies, and other regulatory agencies
• Experience with US 510(k), CE mark (EU MDD/MDR), and other international requirements and submissions
• Experience with product development processes and design controls
• Demonstrated track record of success in leading all areas of regulatory affairs
• Ability to manage multiple direct reports and diverse projects
• Ability to communicate with all levels of management
• Strong project management skills
• Strong leadership and decision-making skills
• Strong negotiation and motivational skills
• Excellent written and verbal communication skills; able to communicate across cultures; collaborate with a cross-functional team; effectively interact with technical and legal associates; and negotiate with Regulators
• Excellent writing skills: able to review and summarize scientific and technical information
• Strong negotiation skills
• Excellent problem solving and analytical skills
• Excellent organizational skills: able to manage multiple tasks and meet timeline commitments
• Ability to work in