Regulatory Affairs Associate II

Overview

The Regulatory Affairs Associate II supports the development, implementation, and management of the department programs, ensuring compliance with applicable agencies and standards. Interacts with individuals at most position levels with occasional contact with representatives from external regulatory agencies to further collaboration. Leads activities related to regulatory affairs both domestically and internationally, working closely with internal teams. Works closely with various departments in coordinating document/records management along with completing administrative tasks.

Responsibilities

• Assist in the development and implementation of proactive programs to support the annual regulatory objectives and adherence to regulatory requirements and ethical behavior.
• Gather regulatory information and provide suggestions for improvement to department management as needed.
• Address common and easy problems with well understood solutions and seeking guidance from others as needed to overcome obstacles.
• Continually improve knowledge of current and pending revisions to regulatory guidelines and safety requirements.
• Establish and maintain the reports calendar for the domestic and global regulatory agencies, scheduling other required submissions as needed.
• Track all pending submissions, loading into the internal database system for electronic approvals, and long-term storage.
• Help design and manage templates to support standardization of submissions, reviewing submissions to ensure they follow the appropriate template and rewriting as needed.

Qualifications

• High school diploma or GED equivalent required, bachelor’s degree in engineering, life science, or other technical discipline preferred.
• 2+ years of related professional experience and including direct experience in regulatory affairs (preferably medical device).
• Working knowledge of the clinical laboratory and healthcare delivery system as it relates to government agencies and the enforcement of associated federal and state regulations.
• Strong research, analytical, and problem-solving skills.
• Ability to set priorities, adapt to changing business needs, and manage multiple assignments within established time frames.
• Ability to work independently and on a team while filling various roles such as team member, etc.
• Ability to efficiently use computer programs necessary to complete work requirements (MS Word, Excel, PowerPoint, etc.)

Physical Requirements

Lifting Requirements – light work or exerting up to 20 pounds of force frequently. Physical Requirements – stationary positioning, moving, operating, ascending/descending, communicating, observing, pushing or pulling, and reaching. Use of equipment and tools necessary to perform essential job functions.