Consultant, Devices

Job Description

Job Description

This posting will close on October 10, 2025.

Position Summary :

The Consultant is a mid-level role responsible for managing and contributing to the successful execution of client projects, within the Medical Device team and on projects that are complex or of a cross-functional nature. This role involves significant involvement in the development and completion of project deliverables, such as technical reports, research, and U.S. Food and Drug Administration (FDA) regulatory submission support. The Consultant may also assist with managing client relationships, support proposal development, and is accountable for meeting individual financial performance targets. The position requires demonstrated subject matter expertise, strong project management and communication skills, and the ability to work effectively across multiple projects and teams. The Consultant is also expected to engage in ongoing professional development and contribute to knowledge-building within their area of specialization.

Biologics Consulting Group, Inc. works with medical device, biologics and pharmaceutical companies to advance patient health.

Essential Responsibilities :

• Assist in the coordination and management of scientific projects within a single area of technical discipline and also across multiple therapeutic areas.
• Contribute to the development of high-quality deliverables, including regulatory documents, technical reports, and literature reviews.
• Provide quality control for work authored by junior team members and ensure deliverables meet client expectations and regulatory requirements.
• Support and contribute to proposal preparation for new business opportunities.
• Manage or support client relationships, including communication and delivery of project milestones.
• Collaborate effectively with team members and cross-functionally across multiple concurrent projects.
• Manage competing priorities effectively while meeting deadlines and maintaining high-quality work.
• Exhibit strong verbal and written communication skills, tailored to scientific and professional audiences.
• Maintain responsibility for meeting individual financial performance targets.
• Participate in ongoing professional development and expand expertise within a specialized subject area.
• Independent use of Quality Management Systems (QMS) software such as Greenlight Guru, Qualio or similar eQMS systems.
• Development and submission of regulatory documents including use of eSTAR and eCOPY
• The incumbent will lead by example and foster a team environment, ensuring an overall ‘culture of quality’ in the high-quality execution of services provided to clients.

Requirements :

Key Performance Indicators :

Essential Skills :

Proficient in Microsoft Office Suite, keyboarding skills, strong documentation skills, math aptitude, diplomacy and leadership skills, professionalism, time management, ability to multi-task, able to work independently as well as collaboratively, and able to maintain confidentiality.

The requirements listed are representative of the knowledge, skill, and / or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.