Senior Manager - Global Regulatory Affairs

As a Sr. Manager - Global Regulatory Affairs, you will be responsible for developing strategic global regulatory plans and preparing 510(k) submissions in support of new and existing marketing authorizations for infusion pumps.

This is a meaningful individual contributor position within the Infusion Therapies and Technologies Regulatory Team and you will be accountable for the relationship with the US Food and Drug Administration and Notified Body for assigned products. Specific activities may include submission planning, creation of 510(k) submission documentation and pre-subs, coordinate, and lead meetings with FDA.

You will evaluate technical and scientific information to manage and maintain operational activities in support of regulatory decisions and existing marketing authorizations . Specific activities may include identification of local submission requirements, product/facility change management, process support, and participation in project teams. You will provide input and help influence global regulatory strategies and be responsible for the execution of regulatory initiatives. You will supervise, evaluate, and interpret applicable regulatory requirements, assure compliance with the company and external standards as well as assess impact of new regulations. You will interface with key business and cross-functional stakeholders and maintain appropriate communication within the RA function, with Marketing, and with other functions primarily at the project team level.

What you'll bring

• Bachelor's degree in a scientific discipline, engineering preferred.
• At least 7 years regulatory experience with recent infusion pump experience preferred; other electromechanical medical device experience will be considered.
• Successful preparation and submission of 510(k)s and international documents or registrations.
• Knowledge of IEC 62304 software development lifecycle and experience in device interoperability preferred.
• Experience with software as a medical device desirable.
• Expert regulatory knowledge and sound scientific skills.
• Ability to manage complex projects and timelines in a multinational/multicultural team environment.
• Strong oral and written communication and presentation skills. Demonstrated interpersonal skills including strong negotiation skills.
• Excellent writing skills to develop clear and logical information and conclusions based on design documentation.
• Identify and prioritize key areas of risk and probability of occurrence as well as ensure implementation of mitigation plans .
• Ability to lead and mentor others.