Regulatory Manager, Capital Equipment

Overview

The Regulatory Affairs Manager manages the processes, procedural work, and reporting of the Regulatory Affairs for Capital Equipment. The RA Manager works directly with the Capital Equipment team and divisions to plan, implement, and improve regulatory strategy globally.

Responsibilities

• Manage workload and workflow of RA Capital Equipment • Communicate directly with RA leadership on proposed improvements• Manage submissions generated for their assigned regulatory area• Actively pursue ways in which to improve the function of the Regulatory Affairs Department (Capital Equipment)• Communicate directly with regulatory agencies and distributors• Manage the progress of Capital Equipment repairs and remove road blocks• Helps refine and implement Regulatory practices/procedures• Effectively communicate with and coordinate resources• Manage accountability within the team to meet established time lines• Accountable for managing and reporting metrics to the RA team• Responsible for performance and wage reviews for team members

• Foster and maintain a workplace culture respectful and supportive of individual differences• Must work and interact effectively and professionally with and for others throughout various levels of the global organization• Must strictly adhere to safety requirements• Maintain regular and punctual attendance• Must maintain company quality and quantity standards• Must have effective oral and written communication skills • Excellent problem solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision • Ability to remain calm and receptive in fast paced situations• Implement policies, programs and directives of senior management• Make recommendations for improvement to Capital Equipment repair processes and tracking

Qualifications

Minimum Work Experience/Educational Requirements

• Minimum 3-5 years Regulatory experience in the medical device field • Previous experience with capital equipment strongly preferred• Bachelor’s degree in a life science (preferably biology or life science) or other related field; or experience of such kind and amount as to provide a comparable background• Completion of RAC preferred

• Proven project leadership skills.• Demonstrated ability to provide consistent leadership in a team setting • Demonstrated ability to manage conflict, communication & resources across multiple projects

 

Physical Requirements/Work Environment

• Requires occasional early morning or evening teleconferences• Must be willing and able to travel as needed• Works under general office environmental conditions• Sits for extended periods, utilizes close visual acuity for working with   computers, etc.