Join Bayer’s Radiology Business unit, where innovation meets expertise in Molecular Imaging. We are dedicated to advancing healthcare through cutting-edge technology and strategic regulatory leadership.

As the Director of Regulatory Affairs, you will represent our medical device regulatory team within the Molecular Imaging platform.  This pivotal role demands a seasoned professional who can drive stakeholder engagement and partner closely with Bayer Pharmaceutical group and other cross functional team members within Bayer Radiology to further our innovation agenda in electromechanical delivery systems for radiopharmaceuticals. You will build and maintain effective relationships with regulators, including the FDA CDRH, relevant Notified Bodies, and key market regulators.

This will be a site-based position based in Indianola, PA or Whippany, NJ. A residence-based option can be available for the selected Candidate.

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Director, Regulatory Affairs, Molecular Imaging, are to:

• Strategic Leadership: Develop and execute a regulatory strategic roadmap for delivery of therapeutic, diagnostic or theranostic radiopharmaceutical ensuring alignment with business objectives on a global scale;
• Collaboration Across Departments: Partner with R&D, medical affairs, clinical development, pharmaceutical colleagues and marketing to integrate regulatory requirements into product development. Provide direction on regulatory pathways for new submissions (e.g., 510K, DeNovo, Combination Products) specific to molecular imaging technologies.
• Regulatory Submission Oversight: Lead the preparation, review, and submission of regulatory filings across the US and EU. Engage directly with regulatory bodies to negotiate approvals and resolve complex regulatory issues effectively;
• Compliance & Policy Contribution: Actively contribute to shaping global regulatory compliance policies and procedures that impact the development of our products;
• Risk Assessment: Identify potential risks associated with regulatory strategies and communicate these to stakeholders while proposing effective mitigation strategies;
• Global Representation: Represent the Bayer Radiology in interactions with global regulatory agencies, Notified Bodies, and at external events such as trade associations and standards development organizations.

WHO YOU ARE

Bayer seeks an incumbent who possesses the following:

Required Qualifications:

• Advanced degree in a technical discipline (e.g., engineering, biology, chemistry, medical physics) is required;
• Current knowledge of global regulations and quality systems are required
• Direct professional experience in Regulatory Affairs within the medical device industry, with significant experience involving medical devices pumping systems, or software-driven electromechanical devices;
• Strong analytical abilities to resolve complex regulatory issues and make sound decisions under pressure;
• Demonstrated leadership capabilities with a focus on team collaboration and mentoring;
• Ability to Travel up to 30%.

Preferred Qualifications:

• 10+ years of experience;
• Experience with molecular imaging technologies is a plus:
• Proven track record of successful negotiations and collaboration with FDA CDRH and Notified Bodies is highly desired.

Employees can expect to be paid a salary of between $171,1700 to $256,700. Additional compensation may include a bonus or commission (if relevant). Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc.. This salary range is merely an estimate and may vary based on an applicant’s location, market data/ranges, an applicant’s skills and prior relevant experience, certain degrees and certifications, and other relevant factors.

This posting will be available for application until at least: 11/20/25.

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