Job DescriptionThe Sr. Regulatory Affairs (RA) Director is responsible for the management, leadership, and setting the direction for multiple product franchises or a business platform, including management of regulatory professionals within those franchises. The Sr. Director is responsible for developing and implementing regulatory strategies and submissions in support of global marketing within their respective platform. The Sr. Director determines priorities and overall structure for their platform and defines and manages expectations for projects. The Sr. Director will work with external contacts, with US and international regulatory authorities, physician advisors, and key industry specialists as related to their product platform. The Director of RA must be knowledgeable about current and possible future policies, practices, trends, technology and information affecting the business and organization.
Responsibilities: - Manages and directs work for one or more RA Platforms or critical programs, including multiple product franchises and associated product lines.
- Provides regulatory leadership for respective RA business platform(s) or RA program(s) and manages individuals and people managers working on RA projects or teams within that platform.
- Recruits, develops, and manages RA professionals with higher levels of seniority, experience, and skills, and ensures regulatory milestones assigned to direct reports are met.
- Responsible for the overall management of RA Professionals within the respective platform, and structures projects and managers appropriately to ensure work is completed efficiently and effectively.
- Develops managers and technical leaders by making accurate assessments of individuals' capabilities and performance, and provides feedback, coaching, guidance and mentoring.
- Manages and directs budget related to Platform(s) and/or projects, including submission costs, travel, and training for teammates.
- Partners proactively in the product development process to provide strategic guidance for development planning from the exploratory phases for new products through the ongoing compliance phases for commercialized products.
- Represents Regulatory in Business Unit and Business Segment meetings.
- Understands and anticipates detailed Regulatory expectations for approval, including precedence and changes in the regulatory landscape.
- Manages communications and negotiates with regulatory agencies on behalf of the business, as they pertain to regulatory decisions and strategies.
- Critically assesses impact of studies and data on project outcome and works with Senior Leadership to determine project strategy.
- Influences all parties to ensure successful submission outcomes, including submission content management.
- Coordinates with Quality function on recall strategies and responses to quality audit findings.
- Ensures consistency of messages delivered via advertising and promotion material in all arenas exposed to customer, as well as for sales training.
- Represents RA in due diligence and participates in product acquisition teams.
- Develops and approves regulatory policies, goals, and executive reports.
- Communicates internal Regulatory Affairs procedures and policies, as needed, to people managers and develops method for communicating to broader regulatory group.
- Develops and influences government position and political decisions in partnership with Legal and Government Affairs.
- Builds relationships with key advocates, regulators and internal/ external stakeholders to ensure that BD point of view is understood and carried forward.
Required Qualifications: - Comprehensive knowledge of United States, European, and international regulations and standards covering medical devices.
- Demonstrated organizational, planning, and program management skills, including action oriented, focused urgency and driving for results
- Experienced in continuous improvement projects, project management, product development processes, and design control.
- Excellent project management skills, with the ability to prioritize and delegate, handling several projects concurrently.
- Effectively copes with change and can comfortably handle risk and uncertainty.
- Prior management experience
Preferred Qualifications: - Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices.
- Ability to be effective in complex projects with ambiguity and/or rapid change
- Demonstrated self-starter, and highly motivated
- Excellent written and verbal communication skills including ability to communicate across culture; work with others in team environment; effective interactions with technical personnel (scientific and legal); and negotiate with Regulators.
- Ability to interpret medical device testing methods and statistics, as applicable.
- Knowledgeable about current and possible future policies, practices, trends, technology and information affecting the business and organization.
- Advance degree preferred.
- Experience with Clinical Trial applications (US IDE).
- Medical device experience in Oncology, ESKD and/or PAD.
Education and/or Experience: - Bachelor's degree or advanced degree in technical area such as biology, chemistry, engineering or medical-related field and a minimum of ten years of experience, or equivalent combination of related education and experience.
- Preferred minimum of ten-to-fifteen years of experience in the medical device industry, with at least ten years in a regulatory role.
Physical Demands: While performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The employee frequently is required to verbally communicate with other associates. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch. Inability to meet one or more of these physical demands will not automatically disqualify a candidate or employee from the position. Upon request, the company may make reasonable accommodations.
Work Environment: While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment.
This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.
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. 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.
Primary Work LocationUSA AZ - Tempe Headquarters
Additional LocationsWork Shift 
