Regulatory Affairs Director

Our vision for Regulatory Affairs at BD

The Regulatory Affairs team is helping to ensure speed to market for BD’s innovative medical technologies by having an acutely patient-centric attitude.

As Regulatory Affairs Director you will define, develop and lead global strategies to improve global regulatory success towards achievement of program objectives for complex projects. In this role you will ensure global regulatory plans accommodate appropriately achievement of business objectives and optimally communicates with project teams, line management and key partners on any developments that may impact regulatory success.

• Provide innovative ways, strategic and tactical mentorship to resolve regulatory issues and increase speed to market
• Ensure high quality collaboration with Regional Regulatory partners by providing timely guidance and partnership in health authority meetings and regulatory documentation spanning throughout the product lifecycle
• Provides guidance on planning, writing and review of dossier documents for submissions globally
• Represent BD in interactions with health authorities for the product portfolio assigned
• Lead cross-functional stakeholder alignment to drive robust regulatory submissions
• Remains on the forefront of the relevant science and competitive landscape via actively contribution to policy shaping efforts including partnering with trade associations; viewed as an expert in its application to the regulatory process
• Coach and mentor team, create an open, inclusive environment for associates to grow and challenge themselves

We are looking for experienced leader in Medical Device Regulatory Affairs with expertise in global regulatory requirements and standards applicable to medical devices (software-hardware integrated technologies, apps, cloud solutions, digital tools) e.g., ISO13485, QSR, EU MDR, US FDA – 510k and PMA.

• Knowledge of and experience in pre-market regulations including regulatory and risk management processes
• Experience in all regulatory compliance aspects of the business: pre-market, commercial, and post-market
• Excellent verbal and written communications skills.
• Strong project coordination, business acumen and negotiation abilities
• Ability to lead, develop and empower multi-cultural and multi-national teams

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.