Head of Regulatory Affairs North America

Fresenius Medical Care • Waltham, MA

22h

About The Position

PURPOSE AND SCOPE: Interfaces with local government regulatory bodies, the FDA, foreign registrars, and regulatory groups as required for product registrations and compliance requirements. Directs and leads a staff of regulatory professionals and develops their expertise in the interpretation and application of appropriate regulations. Responds to FDA and district office requests, as deemed appropriate. PRINCIPAL DUTIES AND RESPONSIBILITIES: Directs and controls the broad activities of Regulatory Affairs Devices through the interpretation, application, and implementation of company-wide policies and processes appropriate to the functional area. Functions as a strategic leader with broad-based knowledge in individual department, and strong knowledge of industry practices and business principles. Works on complex issues and abstract issues/situations where analysis of situations or data requires an in-depth knowledge of the company. 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. Responsible for the development and implementation of clinical strategies. Oversees the preparation and submission of regulatory documentation to the FDA. Responsible for ensuring the quality, content and format or regulatory submissions. Serves as primary FDA contact for projects, as assigned. Interprets and advises on the application of industry regulations and the FDA review process. 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. Manages regulatory projects and plans in accordance with project, department and corporate goals. Prepares internal teams for FDA meetings. Reviews and approves investigator site regulatory documents according to FDA requirements. Develops and coordinates simultaneous strategies/initiatives for direct departments, and contributes to the development of divisional/business unit strategies. Interprets and provides recommendations for change of company-wide policies and practices. Establishes policies appropriate for the function. 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. Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations. Ensures 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. Collaborate with employees in the establishment of clear and concise development plans to ensure succession planning and the advancement of future leaders within 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. Assists with various projects as assigned. 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. SUPERVISION: Responsible for the direct supervision of various levels of Regulatory Affairs Devices staff.

Requirements

• Bachelor’s Degree required in Mechanical or Electrical Engineering or Life Science; Advanced Degree preferred.
• 12+ years of experience in a Medical Device manufacturing company; 5+ years of experience in a senior managerial/director level role.
• Working knowledge of the U.S. Food Drug and Cosmetic Act, and all associated regulations, especially the FDA medical device product approval processes, FDA legislature/regulation, post market approval requirements, and Quality Systems Regulations.
• Working knowledge of Medical Device Directives regarding the same, as well as the current ISO 90200 Quality Systems Standards and AMI Standards.
• Technical knowledge of Medical Devices used in dialysis and renal care.
• Demonstrated leadership ability with project teams and direct report employees.
• Strong interpersonal skills with the ability to communicate with all levels of management through diplomacy and tact.
• Ability to managed multiple and varied tasks; ability to re-prioritize projects on a consistent basis.
• Must be able to work cross functionally within the organization.
• Strong management skills with the ability to lead cohesive and productive teams; influencing skills.
• Excellent oral and written communication skills.

Nice To Haves

• Experience in the Pharmaceutical manufacturing field in addition to Medical Device experience is preferred.
• Knowledge of the Canadian Device and Drug approval process is a plus.

Responsibilities

• Interfaces with local government regulatory bodies, the FDA, foreign registrars, and regulatory groups as required for product registrations and compliance requirements.
• Directs and leads a staff of regulatory professionals and develops their expertise in the interpretation and application of appropriate regulations.
• Responds to FDA and district office requests, as deemed appropriate.
• Directs and controls the broad activities of Regulatory Affairs Devices through the interpretation, application, and implementation of company-wide policies and processes appropriate to the functional area.
• Functions as a strategic leader with broad-based knowledge in individual department, and strong knowledge of industry practices and business principles.
• Works on complex issues and abstract issues/situations where analysis of situations or data requires an in-depth knowledge of the company.
• 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.
• Responsible for the development and implementation of clinical strategies.
• Oversees the preparation and submission of regulatory documentation to the FDA.
• Responsible for ensuring the quality, content and format or regulatory submissions.
• Serves as primary FDA contact for projects, as assigned.
• Interprets and advises on the application of industry regulations and the FDA review process.
• 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.
• Manages regulatory projects and plans in accordance with project, department and corporate goals.
• Prepares internal teams for FDA meetings.
• Reviews and approves investigator site regulatory documents according to FDA requirements.
• Develops and coordinates simultaneous strategies/initiatives for direct departments, and contributes to the development of divisional/business unit strategies.
• Interprets and provides recommendations for change of company-wide policies and practices.
• Establishes policies appropriate for the function.
• Regularly interacts with executives, senior management, and/or major customers.
• Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.
• Ensures 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.
• Collaborate with employees in the establishment of clear and concise development plans to ensure succession planning and the advancement of future leaders within 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.
• Assists with various projects as assigned.
• Other duties as assigned.

Benefits

• This position offers a 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 depending on company and individual performance

What This Job Offers

• Job Type: Full-time
• Career Level: Director