Senior Manager, Regulatory Affairs

The Opportunity:

This new team member is responsible for the management and leadership of the Regulatory Affairs department.  The manager is responsible for allocating and managing department resources to accomplish department and corporate objectives.

Responsibilities:

• Recruit, coach, and develop organizational talent.
• Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Create an entrepreneurial environment.
• Provide direction and guidance to exempt specialists and/or supervisory staff who exercise significant latitude and independence in their assignments.
• May manage and coach a team of regulatory employees.
• Keep the organization’s vision and values at the forefront of decision making and action.
• Demonstrate effective change leadership.
• Build strategic partnerships to further departmental and organizational objectives.
• Develop and execute organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills.
• Monitor compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations, etc.).
• Make decisions regarding work processes or operational plans and schedules in order to achieve department objectives.
• Develop, monitor, and appropriately adjust the annual budget for department(s).
• Develop regulatory strategies, approval schedules, and submission standards to achieve departmental and organizational objectives.
• Assess proposed regulations and communicate new requirements to the organization.
• Monitor costs of projects and of human and material resources within a department or unit.
• Monitor company-wide indicators such as market share and profitability.
• Monitor external environment in area of technical or professional responsibility.
• Develop and/or identify new work processes and the improved utilization of human and material resources within the assigned or related functions or groups.
• Facilitate others’ participation in the continuous improvement program.
• Investigate and solve problems that impact work processes and personnel within or across units or departments.
• Develop and communicate a vision for the organizational unit assigned.
• Provide direction and monitor the progress of exempt specialists and/or supervisory staff toward departmental goals.

Required Qualifications:

• Bachelor’s Degree in a related field or an equivalent combination of education and experience
• Minimum 9 years of related work experience.

Preferred Qualifications:

• Master’s degree
• Submission / registration types and requirements
• Experience working with Class III implantable devices.
• Effective verbal and written communication with diverse audiences and teams.
• Analytical thinking with good problem-solving skills.
• Experience managing and leading a team.
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
• Must be able to lead and manage multiple and competing priorities and manage programs.
• Working knowledge of QSR, ISO, and EN standards. Strong working knowledge of regulatory requirements for US, EU (EU MDR), and other international geographies.
• Experience with medical device software requirements and software regulations.
• Ability to identify risk areas and escalate issues as appropriate.