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, Field Action Management is accountable for leading the Field Action Quality team responsible for the end-to-end Field Action process for all BD business units. The Director partners with Business Unit Leadership (QVPs, MA, RA, VP/GMs) to ensure consistent, customer-centric and compliant field action decisions are reached, and with regional PMQ leads from North America, EMEA, GA and LATAM to ensure their input is included within the FAC decision and global field action execution can be initiated once a decision for a field action is determined.  The Director must also help track and monitor field action execution activities, through closure, occurring within the North America, EMEA, GA and LATAM regions.    

The Director leads a Field Action expert team consisting of Senior Managers and experienced SMEs, manages relationships with FDA, key customers (such as large IDNs) and BD senior leadership supporting the Medical, Interventional and Life Sciences segments.  Additionally, the Director ensures all applicable internal stakeholders are updated on the field action progress and effectively escalates challenges / issues that arise during the process.

The Director engages in direct dialogue and negotiation with FDA on specific topics related to post market quality for all of BDs product families and is an official point of contact for FDA for post market quality related topics. The job holder maintains independence from the BUs and ensures consistency of decision-making standards and operating practices across BDX.

The Director must be a recognized expert in FDA expectations, regulatory standards, and best practices in all areas for which they are accountable. They must have the experience and gravitas to be able to have rules-based discussions with FDA. The job holder is an expert in US Regulations, and supports the BU Legal Manufacturers domiciled in the USA but must also maintain awareness of Global Regulatory expectations so as to be able to fully support the business units when making decisions that could impact other regions.

They will integrate the work within the BUs and Central teams, for example Regulatory Compliance and Quality Systems and evaluate data and trends to determine and present actionable insights to senior BDX review bodies for example CQRB, QRC council and other review boards as required. This requires the job holder to be able to understand the view of FDA, Business and Operations with a patient-centric perspective for all situations and synthesize these into solid and defensible recommendations. 

The job holder must take a lead role in developing the vision for this function, in response to the changing needs in BD and the growing external expectations. They play a key role in assuring stringent compliance requirements and drives timely solutions to immediate challenges.

The Director will be part of the Global Quality Systems Leadership Team and will participate / lead initiatives for the Global Quality Systems LT. As such the job holder needs to be able to operate within a highly complex matrix and aligned with BD’s Values and Strong Teams Operating Model to deliver the goals of the function efficiently and effectively.

They will provide strategic guidance necessary to gain and maintain standards of excellence and will collaborate with the other key functions (RA, Medical, Legal, RC, BU Quality, etc.) to determine and promulgate the BD “line to take” with respect to new and emerging trends and regulations within their area of responsibility.

Primary Duties (essential functions) include:

• Leadership of the Field Action Management organization

• Ensuring compliance with applicable industry regulations
• Drives development, implementation and management of Metrics for Field Actions and reports to Regional, Function and BDX leadership.
• Supports data insight development and continuous improvement projects across BDX
• Partner with and build strong relationships with leaders across all Business Units within BD and their Leaders within the Regions, plus Medical Affairs and RA
• Responsible for promoting and fostering a culture focused on prevention.
• Actively drive key strategic decisions impacting the development of Field Actions
• Develop talent within the organization and act as a mentor both within, and outside of Field Actions.

EXPERIENCE & EDUCATION

• Minimum requirements are a BA/BS degree or equivalent in a Life Science, Engineering, or Physical Science with an advanced technical degree or MBA preferred. 

• Minimum of 10 years of experience in quality management or regulatory with at least 5-7 years of experience in an FDA/Competent Authority regulated environment.
• Minimum of 5-7 years of experience leading teams; experience leading leaders is preferred.
• Demonstrated ability to lead and develop high performing teams, including, talent management and fostering a culture aligned with BD Values.
• Demonstrate ability to operate cross-functionally, remove silos and Win as one BD.
• Demonstrated comprehensive expertise in the applied interpretation of worldwide regulatory standards and laws applicable to field actions within the medical device, in vitro diagnostics and / or pharmaceutical industries, e.g., 21 CFR Parts 7, 806, 820, ISO 13485.
• Demonstrated expertise in working with Agencies to address issues and a proven track record of successful interactions with FDA.
• Excellent written and oral communication
• Ability to continuously assess the effectiveness of functional processes and to lead progressive improvement initiatives applying principles of process excellence.
• "Out of box" strategic thinker with strong, cross-functional leadership ability.
• As a change agent, motivated to improve organizations and not be satisfied with status quo.

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 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 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.   

To learn more about BD visit https://bd.com/careers 

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not 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 legally-protected status. 

Required Skills

Optional Skills

.

Primary Work Location

Additional Locations

Work Shift

At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.

Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.

Salary Range Information