Principal RA Associate Devices

Overview

The position focuses on developing regulatory strategies for assigned products/product lines, preparing regulatory submissions, and ensuring compliance with all regulatory requirements.

Success Profile

A successful candidate will have a Bachelor’s Degree, minimum 8 years of related submission experience, and prior 510(k) experience. They should demonstrate strong communication, problem-solving, and organizational skills, and be able to work independently and manage multiple projects.

Rewards

• Competitive annual rate ranging from $109,000 to $183,000
• Comprehensive benefits package including medical, dental, and vision insurance, a 401(k) with company match, paid time off, parental leave, and potential for performance-based bonuses
• Drug-free workplace policy
• Equal opportunity employer

Connect

Fresenius Medical Care offers a supportive and dedicated team environment where employees can make a meaningful impact on patients' lives. The company values compassion, leadership, and teamwork, and encourages applicants who embody these qualities to apply.

Purpose and Scope

Develops regulatory strategies for assigned products/product lines, prepares regulatory submissions, and ensures compliance with all regulatory requirements.

Principles and Practices

• Understands and interprets U.S. and international medical device regulatory requirements
• Develops strategies for submissions to FDA and other regulatory agencies
• Assists in short and long-term schedule planning for the product development team
• Prepares FDA submissions necessary for new product approvals/clearances
• Maintains regulatory procedures and policies to ensure ongoing compliance
• Coordinates preparation of additional information and data requested by regulatory agencies
• Independently reviews and approves relevant documents
• Manages projects and allocation of resources

Physical Demands and Working Conditions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 10-15% domestic and international travel as required.

Education and Experience

Bachelor’s Degree required; Advanced Degree preferred. Minimum 8 years’ related submission experience. Experience should include effective interaction with manufacturing, quality, clinical/medical, and marketing departments. Prior 510(k) experience required. Experience with international regulations preferred. Previous supervisory experience a plus.

Skills

• Demonstrated working knowledge of scientific principles
• Demonstrated ability to work effectively in a highly charged, fluid environment
• Demonstrated ability to independently manage multiple projects
• Self-starter with the ability to work independently and as a Project Leader who will manage projects and allocate resources to those projects
• Very detail-oriented, well-organized, and driven to meet deadlines and program goals
• Strong verbal and written communication skills, including the ability to make effective and persuasive presentations
• Good computer skills with knowledge of Microsoft Office

Benefits

• Comprehensive benefits package including medical, dental, and vision insurance, a 401(k) with company match, paid time off, parental leave, and potential for performance-based bonuses
• Drug-free workplace policy
• Equal opportunity employer

Company Culture

Fresenius Medical Care values compassion, leadership, and teamwork. The company encourages applicants who embody these qualities to apply.