Sr. Director, RA

About the role

The 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.

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.
• Manages and directs budget related to Platform(s) and/or projects, including submission costs, travel, and training for teammates.
• Presents Regulatory in Business Unit and Business Segment meetings.
• Understands and anticipates detailed Regulatory expectations for approval, including precedence and changes in the regulatory landscape.
• 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.
• Captures and 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.

Requirements

• 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.

Qualifications

• 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.

Skills

• 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.
• 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.
• Knowledgeable about current and possible future policies, practices, trends, technology and information affecting the business and organization.
• RAC certification.
• Experience with Clinical Trial applications (US IDE).
• Medical device experience in Oncology, ESKD and/or PAD.

Benefits

BD offers a comprehensive benefits package including health insurance, retirement plans, and paid time off.

Pay

Competitive salary based on experience and qualifications.

Schedule

Flexible schedule to accommodate the needs of the employee and the business.