Vice President, Head of Regulatory Affairs

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us.

If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

This position is responsible for all Regulatory activities for New Product Development (NPD), line extensions and Life Cycle Management (LCM) activities designed to optimize the value of the products across the Radiology Medical Device (MD) portfolio.

This includes the overall regulatory responsibility to obtain most rapid product approvals /registrations with competitive labeling and ensure optimal regulatory compliance for the Radiology MD portfolio and oversee the preparation of business-critical regulatory submissions including FDA (510 (k)) submissions to secure marketing clearance.

The position oversees a team of Global Regulatory Strategists and Labeling Strategists regarding regulatory strategy, objectives, policies and programs pertaining to development, labeling, and marketing of the Radiology Medical Device portfolio.

The primary responsibilities of this role, Vice President, Head of Regulatory Affairs Medical Devices, Radiology are to:

VACC Leadership:
Act as a VACC (Visionary, Architect, Catalyst, Coach) leader. Be a role model for embracing and actively championing the DSO operating model and behaviors, empowering teams to drive outcomes, take ownership, and act with agility.

Team Leadership:

• Effectively leads, trains, and coaches a home team of Global RA colleagues who provide the regulatory expertise and leadership of the Radiology R&D portfolio.
• Ensures talent management, succession planning and people development for the Regulatory Affairs MD group.

Strategic Leadership:

• Contributes as a member of the Radiology RA LT to the overall Radiology RA vision and strategy.

Portfolio Oversight:

• Leads the strategic direction of all Regulatory matters associated with the Bayer Radiology business portfolio with the aim of developing and executing optimal Regulatory product development and maintenance strategies to optimize Bayer Radiology’s commercial objectives.
• Oversees project compliance, including change management and LMR review, with all applicable regulations and standards and proactively monitors the competitive landscape and advises organization on actions to be taken regarding opportunities or threats.

Strategic Input:

• Provides regulatory and scientific input and expertise to R&D teams regarding strategic MD development decisions, including the robust assessment of external opportunities.
• Advises Global Regulatory management and/or other functional areas of regulatory trends and their relevance to Bayer Radiology MD projects.
• Feeds Bayer Radiology’s growth by ensuring a state-of-the‑art product development RA strategy which ensures that MD products are approved efficiently and positioned competitively in the global marketplace.

Value Creation:

• Fosters a positive development of the net present value (NPV) of the pipeline and ensures that resources are optimally used and productivity improvements are achieved.

Regulatory Interaction:

• Contributes to medical and scientific dialogue with regulatory health authorities globally.

Bayer seeks an incumbent who possesses the following:

• • Bachelor’s degree

• R…