COMPANY: Medical Device Start-Up
JOB DESCRIPTION:
The Manager of Regulatory Affairs is responsible for the management and strategic leadership of the Regulatory Affairs department. This role includes allocating and managing department resources to accomplish department and business objectives.
JOB REQUIREMENTS:
- Develop regulatory strategies, approval schedules, and submission standards to achieve departmental and business objectives.
- Provides direction and guidance to staff/consultants who posses experience to exercise significant latitude and independence in their assignments.
- Builds strategic partnerships with R&D and Clinical to accomplish departmental and business objectives.
- Builds partnerships with FDA, VMI’s notified body, EU competent authorities and other regulators.
- Develops and executes organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills.
- Monitors compliance with company policies and procedures (e.g. compliance with FDA, EU regulations, etc.).
- Makes decisions regarding work processes or operational plans and schedules in order to achieve department/business objectives.
- Develops, monitors, and appropriately adjusts the annual budget for department/projects.
- Assess proposed/new regulations and communicate new requirements to the organization.
- Responsible for compliance with applicable VMI Policies and procedures.
SKILLS AND EXPERIENCE:
- Minimum of ten years experience in Regulatory Affairs and with a minimum of five years experience with medical devices and PMA/PMAS submission processes
- General knowledge of catheter technologies, cardiac/cardiovascular anatomy & disease and electrophysiology clinical procedures/equipment
EDUCATION: List minimum education required.
- BS degree in Engineering or Life Sciences
This is a FULL-TIME position, M-F
If you are interested, please submit your resume by email (cut and paste text only, NO ATTACHMENTS), with REGULATORY AFFAIRS MANAGER in the subject line, your salary requirements and a brief description as to why you would be a good match for this position.
NO RECRUITERS PLEASE
- Compensation:
- Principals only. Recruiters, please don't contact this job poster.
- Please, no phone calls about this job!
- Please do not contact job poster about other services, products or commercial interests.