Description
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.
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.
YOUR TASKS AND RESPONSIBILITIES
The primary responsibilities of this role, Vice President, Head of Regulatory Affairs Medical Devices, Radiology are to:
- Act as a VACC (Visionary, Architect, Catalyst, Coach) leader.
- Effectively lead, train, and coach a home team of Global RA colleagues who provide the regulatory expertise and leadership of the Radiology R&D portfolio.
- Ensure talent management, succession planning and people development for the Regulatory Affairs MD group.
- Contribute as a member of the Radiology RA LT to the overall Radiology RA vision and strategy.
- Lead 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.
- Provide regulatory and scientific input and expertise to R&D teams regarding strategic MD development decisions.
- Foster a positive development of the net present value (NPV) of the pipeline and ensure that resources are optimally used and productivity improvements are achieved.
- Contribute to medical and scientific dialogue with regulatory health authorities globally.
WHO YOU ARE
Bayer seeks an incumbent who possesses the following:
- Bachelor's degree
- 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.
- 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.
- Longstanding relevant professional experience in R&D, Quality, or Regulatory Affairs within the Health Care industry.
- Outstanding track record of leading teams and managing Global Regulatory Experts within agile or matrixed environments.
- Strong aptitude to set a vision for an organization, develop corresponding strategies, and mobilize employees to achieve their objectives.
- Seasoned VACC leadership and interpersonal skills.
Preferred Qualifications:
- Ph.D., M.D., P.Eng. or PharmD Regulatory device 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. Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc.