Vice President, Head of Regulatory Affairs

Bayer•Indianola, PA

3d•Onsite

About The Position

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.

Requirements

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.
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.
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; 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.

Nice To Haves

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

Responsibilities

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.
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.
Contributes as a member of the Radiology RA LT to the overall Radiology RA vision and strategy.
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.
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.
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.
Contributes to medical and scientific dialogue with regulatory health authorities globally.