Regulatory Affairs Fellow - Devices

This position can be fully remote and located anywhere in the US.

PURPOSE AND SCOPE:

Develops regulatory strategies for assigned products/product lines. Prepares regulatory submissions required to market new or modified medical devices in the domestic and international clinical markets. Develops and maintains procedures and systems designed to ensure the product development process addresses all regulatory requirements as well as the objectives of the business.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Coordinates preparation of additional information and data requested by regulatory agencies and prepares appropriate responses to such requests.
• Other duties as assigned.
• Develops and maintains regulatory procedures and policies to ensure ongoing compliance of existing and new products.
• Independently reviews and approves relevant documents, including engineering changes, advertising and promotional materials and product development reports.
• Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations.
• Assists with various projects as assigned by direct supervisor.
• Mentors other staff as applicable.
• Has broad expertise or unique knowledge; uses skills to contribute to the development of company objectives and principles, and achieve goals in creative and effective ways.
• Responsible for day-to-day oversight and management of assigned projects. Serves as primary regulatory resource for change to and prioritization of projects, resource assignment and efficient management of the development and change processes.
• Develops strategies for submissions to FDA and other regulatory agencies. Provides regulatory risk assessments and options to product development teams and management.
• Responsible for the preparation of Regulatory Assessment and Notes to File for assigned projects.
• Acts independently to determine methods and procedures on new or special assignments. May supervise the activities of others.
• Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles. Exercises judgment in methods, techniques and evaluation criteria for obtaining results.
• Understands and interprets U.S. and international medical device regulatory requirements; provides guidance on requirements to product development teams.
• Assists with regulatory agency interactions.
• May provide leadership and direction to assigned resources. Provides timely and appropriate performance feedback.
• Responsible for preparing FDA submissions necessary for new product approvals/clearances which include Premarket norifictoins-510(k)s, Premarket Approval Applications (PMAs) and supplements, Investigational Device Exemptions (IDEs) submissions.
• Creates formal networks involving coordination among groups.
• Assists in short and long-term schedule planning for the product development team.

Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.

PHYSICAL DEMANDS AND WORKING CONDITIONS:

• 10 – 15% domestic and international travel as required.
• The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION:

Bachelor’s Degree required; Advanced Degree preferred.

EXPERIENCE AND REQUIRED SKILLS:

• Good computer skills with knowledge of Microsoft Office.
• Very detail-oriented, well-organized and driven to meet deadlines and program goals.
• Minimum 12 years of related experience; or a Master’s degree with 8 years of experience.
• Demonstrated ability to work effectively in a highly charged, fluid environment.
• Demonstrated working knowledge of scientific principles.
• Demonstrated ability to independently manage multiple projects.
• Previous supervisory experience a plus.
• Strong verbal and written communication skills, including the ability to make effective and persuasive presentations.
• Prior 510(k) experience required.
• Experience with international regulations preferred.
• As self-starter with the ability to work independently and as a Project Leader who will manage projects and and allocation of resources to those project.
• Experience should include effective interaction with manufacturing, quality, clinical/medical and marketing departments.

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.