Director Regulatory Strategy Devices - Bayer Corporation

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.

Director Regulatory Strategy Devices  

PURPOSE

This position develops and implements Regulatory activities for keydevice specific New Product Development (NPD) and line extensions for medical device (MD) and digital development projects and LCE projects for Bayer Radiology with little direct oversight. This includes responsibility for the development, alignment and implementation of regulatory strategies in support of product initiatives. Additionally, this position prepares business-critical regulatory submissions for projects (510(k), international submissions) to secure FDA and international marketing clearance as well as preparation and maintenance of technical documentation in compliance with the European Medical Device Regulations. The position also provides regulatory support for cross-functional coverage of critical topics for the Bayer Radiology medical device business. The position contributes and supports strategy coordination of a team of Regional/Local Regulatory Managers.

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of the Directoir Regulatory Strategy Devices are to:

• Develops and implements global Regulatory strategies for new product development digital projects, ensuring that pre-market digital Regulatory requirements are captured in global regulatory strategies and development plans, while balancing business objectives
• Develops and implements regional/local Regulatory project goals for key digital projects.
• Leads and/or participates on key NPD Regulatory Affairs Teams and/or Global Project Teams.
• Leads preparations and conduct/follow-up for top priority project meetings and teleconferences with US/Can/EU health authority officials and aids in other country health authority meeting preparation/conduct/follow-up.
• Responsible for the preparation of key 510(k) and international submissions for digital projects as well as preparation and maintenance of EU technical files to ensure European Medical Device Regulations compliance.
• Ensure digital submissions and technical documentation are consistent with the business strategy. For digital projects, develop regional/local submission/technical documentation materials, guide the review process, check for accuracy, technical consistency, compliance to local and global health authority regulations and completeness of submission.
• Clearly communicates recommended digital strategies and changing local digital regulatory requirements, including necessary adaptions to peers, senior management and cross-functional teams.
• Ensures digital device compliance, including change management and ad/promo review, with all applicable regulations and standards and proactively monitors the competitive landscape and advises the organization on actions to be taken regarding opportunities or threats.
• Proactively identifies device regulatory issues/risks and leads/executes mitigation plans.
• Acts as a company liaison to industry trade associations for digital topics. Reviews and suggests possible organization reaction to new or proposed digital legislation.
• Provides Regulatory support and cross-functional activity for assigned digital device product recalls and risk management documentation.
• May work on assigned special projects such as contributing to Regulatory Affairs functional improvement initiatives. The incumbent should be capable of performing these tasks with little to no supervision.  

WHO YOU ARE
Your success will be driven by your demonstration of our life values, more specifically related to this position, Bayer seeks an incumbent who possesses the following:

REQUIRED QUALIFICATIONS
 

• Ph.D., M.D., P.Eng. or PharmD with a minimum of 5 years of Regulatory device experience; or a Master's with a minimum of 7 years of Regulatory device experience; or a Bachelor's degree with a minimum of 9 years of Regulatory device experience. 
• Proven experience and demonstrated innovation working with medical devices. (FDA Class II or Class III) 
• Strong knowledge of Quality System Regulations. 
• Proven experience in submissions for software as a medical device. 
• Familiarity and positive interactions with key Health Authorities.
• Ability to articulate and solve complex regulatory device issues independently.
• Strong ability to communicate and negotiate effectively in English both verbally and in writing.
• Experience working with cross-functional teams. 
• Strategic and results oriented