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Director, Regulatory Affairs - Devices

Current Employee? Job ID 17000FAP

Fresenius Medical Care North America is the premier health care company focused on delivering the highest quality care to people with renal and other chronic conditions.

Worldwide, more than 2.5 million patients with this disease regularly undergo dialysis therapy, a vital blood cleansing procedure that substitutes the function of the kidney in the case of kidney failure.
Through our industry-leading network of more than 2,200 dialysis facilities, outpatient cardiac and vascular labs, and urgent care centers, as well as the country’s largest practice of hospitalist and post-acute providers, Fresenius Medical Care provides coordinated health care services at pivotal care points for hundreds of thousands of chronically ill customers throughout the continent. As the world’s only vertically integrated renal company, we also offer specialty pharmacy and laboratory services, as well as manufacturing and distributing the most comprehensive line of dialysis equipment, disposable products and renal pharmaceuticals.
Our integrated approach helps to not only improve patients' health outcomes, but also reduce the total cost of care.
Around the world, we care for more than 290,000 renal patients in our global network of more than 3,400 dialysis clinics. At the same time, we operate more than 40 production sites on all continents, to provide dialysis products such as dialysis machines, dialyzers and related disposables.
Our strategy is geared toward sustainable growth. We aim to continuously improve the quality of life of patients with kidney disease by offering innovative products and treatment concepts of the highest quality.
Fresenius Medical Care’s corporate headquarters is in Bad Homburg, Germany. Our North American headquarters is in Waltham, Massachusetts and our Asian-Pacific headquarters is located in Hong Kong.

KEY RESPONSIBILITIES

Supports FMCNA's new medical device and marketed product development. Directs and oversees the preparation of U.S. regulatory submissions for new products.  Investigates and implements changes to existing products in compliance with applicable international and U.S. federal laws. Provides leadership to a staff of regulatory professionals engaged in preparation of regulatory submissions in support of new product development and changes to existing products. Maintains compliance with U.S. and appropriate international regulatory requirements.

  • Directs and oversees the broad activities of Regulatory Affairs – Devices. Responsible for managing the preparation and submission of regulatory documentation to FDA. Ensures the quality, content, and format of regulatory submissions at all times.
  • Responsible for the development and implementation of FDA submission strategies and clinical strategies.
  • Serves as primary FDA contact for projects, as assigned.
  • Interprets and advises on the application of industry regulations and the FDA review process.
  • Provides regulatory guidance regarding advertising and promotional literature.
  • Responsible for determining development and filing strategies related to all post 510(k) clearance changes.
  • Fosters positive and effective working relationships between project team members and health authority reviewers.
  • Coordinates and consults with other departments regarding the content, review, and assembly of regulatory documentation.
  • Oversees regulatory projects and plans in accordance with project, department, and corporate goals.
  • Prepares internal teams for FDA meetings.
  • Ensures that budgets and schedules are within company requirements with significant organizational responsibility for the overall control of planning, staffing, budgeting, expense priority management, and recommendation and implementation changes of current methods.
  • Interprets and provides recommendations for change of company-wide policies and practices.  Establishes policies appropriate for the function.
  • Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations.
  • Ensure all employees within the assigned team(s) understand and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations; establishing and maintaining effective internal systems and controls to promote compliance.
  • Provides leadership, guidance, and coaching for all direct reports to maintain an engaged and productive workforce; partnering with Human Resources on employee matters.
  • Collaborates with employees in the establishment of clear and concise development plans to ensure succession planning and the advancement of future leaders within the organization.
  • Regularly interacts with executives, senior management, and/or major customers.  Interactions frequently require special skills such as negotiating or influencing customers and/or senior level leaders in matters of significance to the organization.
  • Interacts with all levels within the organization to manage functional area.  Overall responsibility for hiring, coaching and counseling employees, including performance reviews, disciplinary action and terminations.
  • Provides technical guidance.
  • Assists with various projects as assigned.


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.

Up to 20% travel may be required.

SUPERVISION:

Responsible for the direct supervision of various levels of Regulatory Affairs staff.

EDUCATION:

Bachelor’s Degree required, preferably in a science related field; Advanced Degree preferred.

EXPERIENCE AND REQUIRED SKILLS:

  • 10+ years of related experience within a medical device company, or similar organization; 5+ years of experience in a senior managerial role.
  • Demonstrated aptitude for managing projects and teams.
  • Experience should include effective interaction with manufacturing, quality, clinical/medical and marketing departments.
  • Prior 510(k) experience required
  • Experience with international regulations preferred.
  • Demonstrated working knowledge of scientific principles
  • Demonstrated ability to work effectively in a highly charged, fluid environment.
  • Demonstrated ability to independently manage multiple projects.
  • A self-starter with the ability to work as a Project Leader managing projects and allocation of resources to those projects.
  • Broad based knowledge of regulations and guidelines governing device development including the ability to apply this knowledge to overall strategic device development
  • Ability to manage multiple and varied tasks; ability to re-prioritize projects on a consistent basis.
  • 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

Current Employee?