Responsible for ensuring regulatory strategies for MSD products are implemented as well as providing project teams with regulatory guidance in compliance with active MSD regulatory certifications and per defined project goals.
Maintain regulatory processes that are in compliance with company policies, FDA regulations, ISO 13485:2003 and other regulatory requirements as applicable.
Implement and maintain SOPs for the documentation and execution of the company's regulatory strategies
Provide regulatory guidance to project teams
Serve as regulatory contact for external vendors for regulatory submission projects
Provide regulatory review of documents needed for project teams and products, including product requirements and specifications, labeling, advertising and promotional materials
Evaluate changes to regulations that impact MSD's quality management system and active regulatory clearances
Coordinate preparation of regulatory submissions.
Ensure submissions comply with applicable regulations and guidance documents
Track submissions and ensure timely filing of documents
Draft general regulatory portions of submissions
Review technical portions of submissions
Coordinate responses to input from regulatory agencies
Specific duties may vary depending upon departmental requirements
EXPERIENCE AND QUALIFICATIONS:
Bachelor's degree in a Health or Science field
Minimum two (2) years of experience in regulatory affairs in an ISO or QSR environment
In vitro diagnostics experience is strongly preferred
Experience in both U.S. and international regulatory requirements is strongly preferred
Regulatory Affairs Certification (RAC) a plus
Strong knowledge of FDA and ISO regulations for in vitro diagnostic devices
Excellent oral, written communication and interpersonal skills
Effectively communicate regulatory strategy and requirements to project teams
Proficiency in MS Office Suite
Must work effectively with a team and individually
Excellent organizational skills and the ability to multi-task; detail oriented
Ability to evaluate regulatory documents and determine appropriate action
A wide degree of creativity and latitude is expected including the ability to multi-task and work productively in a demanding production environment with changing priorities
This position requires the ability to communicate and exchange information, utilize equipment necessary to perform the job, and move about the office.
