Vice President, Head of Regulatory Affairs

Bayer; Indianola (PA); Presencial; USD 273.000 - 409.000; Jornada completa

Descripción de la vacante

Bayer in the United States, Pennsylvania (Indianola) seeks a Vice President, Head of Regulatory Affairs for Medical Devices in Radiology. You will lead regulatory strategy, global submissions (FDA 510(k)) and oversee a team of strategists and labeling experts to optimize development and lifecycle management.

The ideal candidate brings deep device regulatory knowledge, cross‑functional leadership, and strong authority with health agencies.

Formación

• Bachelor’s degree in regulatory or scientific field.
• Deep regulatory expertise in medical device regulations (FDA/EU).
• Proven track record of successful approvals in device areas.

Responsabilidades

• Provide regulatory leadership for Medical Devices in Radiology.
• Oversee regulatory strategy, submissions (FDA 510(k)) and lifecycle management.
• Lead and coach Global Regulatory Strategists and Labeling Strategists.
• Collaborate with R&D, QA, and global health authorities.

Conocimientos

Regulatory leadership

Regulatory strategy

Global regulatory experience

Team leadership

Communications skills

Educación

Bachelor’s degree

Ph.D., M.D., P.Eng. or PharmD Regulatory device experience; or Master’s with Regulatory device experience and managerial experience

Descripción del empleo

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.

Vice President, Head of Regulatory Affairs

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.

YOUR TASKS AND RESPONSIBILITIES

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.

WHO YOU ARE

Bayer seeks an incumbent who possesses the following:

Required Qualifications:

• • Bachelor’s degree

Scientific Expertise:

• Regulatory / Scientific expertise with a deep understanding of Medical Device regulations.
• In‑depth knowledge of the Regulatory Affairs environment and requirements and proven track record of successful approvals in device areas.
• Knowledge of global development processes for devices and establishing relations with Health Authorities, Notified Bodies and distributors.
• Strong working knowledge of Quality System Regulations, Medical Device Regulations, international regulations, FDA guidance, and international standards.
• Expertise in FDA 510(k) and EU medical device /technical documentation requirements.

Industry Experience:

• Longstanding relevant professional experience in R&D, Quality, or Regulatory Affairs within the Health Care industry.

Leadership Track Record:

• Outstanding track record of leading teams and managing Global Regulatory Experts within agile or matrixed environments.

Strategic Vision:

• Strong aptitude to set a vision for an organization, develop corresponding strategies, and mobilize employees to achieve their objectives.

DSO & VACC Champion:

• Seasoned VACC leadership and interpersonal skills; ability to work collaboratively, catalyze cross‑functional teams, and coach individuals to reach their highest potential.
• Thrives at dealing with ambiguity and overcoming complexity in a challenging multi‑national environment.
• Remains current with rapidly changing regulatory requirements across diverse global markets.
• Leans into change and possess the ability to effectively work in an international and multicultural environment.
• Established ability to build effective relationships with health authorities. Demonstrated successful interactions with local and global Health Authorities.
• Excellent communication and negotiation skills with high credibility. Demonstrated ability to articulate and solve complex regulatory device issues
• Strong focus on the achievement of goals and demonstrated decision‑making skills.
• Self‑assured and comfortable defending positions with high‑level executive management.
• Demonstrated ability to articulate and solve complex regulatory device issues.

Preferred Qualifications:

• Ph.D., M.D., P.Eng. or PharmD Regulatory device experience; or Master's with Regulatory device experience and managerial experience
• Talent Management: Ability to attract, develop, and retain top talent.

Employees can expect to be paid a salary between $272880.00 to $409320.00. 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 10/30/2026.

To all recruitment agencies: Bayer does not accept unsolicited third party resumes.

Bayer is an Equal Opportunity Employer/Disabled/Veterans

Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.

Equal Opportunity Employer Statement: Notice for U.S. Visitors: All information on this site is subject to compliance with local rule and regulations as they may vary from time to time and across different geographies, including, without limitation, U.S. Executive Orders. Bayer is an E-Verify Employer.

Location: United States : Pennsylvania : Indianola Division: Pharmaceuticals Reference Code: 890300 Contact Us Email: [e-mail]