Director Infusion Systems

Director Of Regulatory Affairs

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

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 will be supported to learn, grow, and become your best self. Become a maker of possible with us.

The Director of Regulatory Affairs reports directly to the Senior Director of Regulatory Affairs. This position is responsible for supporting MMS Infusion products consisting of Medical Devices along with associated Software and Accessories on a global basis from a Regulatory Affairs standpoint. Support will consist of new product development, sustaining, and end of life activities. The Director will oversee the hiring, training, and career development of their reports.

Responsibilities :

• Lead and develop direct report associates to ensure regulatory compliance
• Problem solve and escalate regulatory and compliance issues to senior management as vital
• Provide effective leadership and team development, effective communication, and quick responses to customers
• Drive continuous improvement in internal processes and customer satisfaction
• Identify, develop, and mentor impactful regulatory talent
• Author and organize regulatory submission content (510(k), Technical Files, etc.)
• Develop and implement global regulatory strategy for MMS Dispensing Medical Device and non-Medical device products and software
• Lead regulatory effort to comply with new and existing regulations (e.g., FDA Medical Device Regulations, EU-MDR)
• Support the monitoring, interpreting, and implementing of current and new regulatory requirements and international standards for U.S., EU., and RoW
• Assure that QMS requirements are followed and executed consistently from RA perspective
• Oversee efforts for Technical File creation and remediation, collaborating with cross-functional teams for required content
• Support regulatory impact assessments for change controls and other RA / QA items from a review and approve level
• Assists in preparing, auditing, editing, and publishing registration documentation, as needed
• Support business export control (BEC) listing of product for release globally per RA requirements
• Support the review and approval of product labeling, promotional, and advertising materials as needed
• Performs other duties and assignments as required

Qualifications :

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.

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 future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.

Becton, Dickinson and Company is an Equal Opportunity / Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Salary Range Information $179,200.00 - $322,500.00 USD Annual