Remote - Principal Regulatory Affairs Associate - Devices - Fresenius Medical Care Holdings, Inc.

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:

• Responsible for the day-to-day oversight and management of assigned projects.  Serves as the primary regulatory resource for change to and prioritization of projects, resource assignment and efficient management of the development and change processes.
• Has wide-ranging experience, and uses professional concepts in developing resolution to critical issues and broad design matters.
• Understands and interprets U.S. and international medical device regulatory requirements, provides guidance on requirements to product development teams.
• Develops strategies for submissions to FDA and other regulatory agencies.  Provides regulatory risk assessments and options to product development teams and management.
• Assists in short and long-term schedule planning for the product development team.
• 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.
• Responsible for the preparation of Regulatory Assessment and Notes to File for assigned projects.
• Coordinates preparation of additional information and data requested by regulatory agencies and prepares appropriate responses to such requests.
• Independently reviews and approves relevant documents, including engineering changes, advertising and promotional materials and product development reports.
• Develops and maintains regulatory procedures and policies to ensure ongoing compliance of existing and new products.
• Assists with regulatory agency interactions.
• May escalate difficult/complex issues to supervisor/manager for resolution, as deemed necessary.
• May provide leadership and direction to assigned resources.  Provide timely and appropriate performance feedback.
• Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.
• Assist with various projects as assigned by a direct supervisor.
• Other duties as assigned.

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:

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.

10 – 15% domestic and international travel as required.

EDUCATION:

Bachelor’s Degree required; Advanced Degree preferred

EXPERIENCE AND REQUIRED SKILLS:

• 8 – 12 years’ related experience; or a Master’s degree with 6 years’ experience; or a PhD with 3 years’ experience; or equivalent directly related work 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.
• Demonstrated working knowledge of scientific principles.
• Demonstrated ability to work effectively in a highly charged, fluid environment.
• Demonstrated ability to independently manage multiple projects.
• 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.
• 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.

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.