Senior Manager, Regulatory Affairs

JOB DESCRIPTION:

A healthy heart is essential to good health. That’s why we’re committed to advancing treatments for people with cardiovascular disease. As a global leader in Cardiac Rhythm Technologies, our breakthrough medical technologies help restore people’s health so they can get back to living their best lives, faster. We focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias or irregular heartbeats.

The Senior Manager, Regulatory Affairs position lead a team responsible for the preparation and submission of regulatory approvals and acts independently to identify and resolve problems. Provides regulatory guidance to cross-functional partners and demonstrates strategic thinking and creativity in support of programs.

RESPONSIBILITIES:

• Prepares robust regulatory applications to achieve departmental and organizational objectives.
• Creates, reviews, and approves engineering changes.
• Acts as a core team member providing review and analysis of applicable regulatory guidelines and project regulatory assessments as needed.
• Reviews and evaluates communications to ensure all necessary details adhere to applicable regulatory standards including those set by the FDA or other worldwide regulatory agencies.
• Maintains pertinent domestic and international medical device regulations to ensure submission requirements worldwide are current, up-to-date, and are entered into the regulatory submission database and file systems. 
• Ensures information on regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel.
• Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.
• Reviews protocols and reports to support regulatory submissions.
• Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with global regulations and regulatory requirements, Company policies, operating procedures, processes, and task assignments. 
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

EDUCATION AND EXPERIENCE:

Required

• Bachelors Degree (± 16 years) or an equivalent combination of education and work experience
• Related experience with medical device development and/or hardware, software, digital health, remote care
• Experience with US submissions; 510(k), PMA, PMA Supplements, IDEs) and/or EU submissions (EU MDR Technical Documentation) preferred
• Experience working in a broader enterprise/cross-division business unit model preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.      
• Strong verbal and written communication with the ability to effectively communicate at multiple levels in the organization. 
• Multitasks, prioritizes, and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.        
• Ability to travel approximately 5-10%, including internationally.

Preferred

• Master’s degree preferred
• Experience with active implantable medical devices and connected systems