Principal Consultant - Medical Devices

Who we are
Science Group provides independent advisory and advanced product development services focused on science and technology initiatives. We operate at the cutting edge of science and innovation, supporting our clients under five specialist brands: Sagentia, Oakland Innovation, OTM Consulting, Leatherhead Food Research and TSG Consulting.

We have a global reach with a multinational and multicultural workforce spanning the U.K., Europe and North America that fuels our success. Whether one of our scientists, engineers, regulatory advisors, market-experts, or central support staff, we look for exceptional hands-on employees that will flourish in a dynamic and stimulating environment.

TSG Consulting offers competitive wages and benefits to qualifying candidates. TSG distinguishes itself by providing the highest possible professional standards in regulatory consultancy services to the consumer product, chemical, medical device and biotechnology industries worldwide. As a Principal Consultant, you will be responsible for continuing to build and maintain TSG’s professional excellence in the medical device regulatory/technical service practice area.

The opportunity
We are actively seeking a senior-level consultant to build and lead our medical device service offerings. The incumbent must have previous experience in medical device regulatory compliance. The preferred location for this role is Washington DC or Sacramento, California.

Responsibilities include but are not limited to:
• Build and drive the regulatory medical device practice area in coordination with other Science Group sister companies.
• Provide technical and regulatory support for obtaining the premarket clearance of medical devices regulated by the United States Food and Drug Administration (FDA)
• Develop the appropriate regulatory strategies to ensure efficient premarket clearance for various types of medical devices
• Draft of product development plans encompassing the scientific rationales and (non)clinical studies necessary to obtain premarket clearance, in consultation with other subject matter experts (e.g. toxicologists, chemists, engineers) as required
• Review and oversight of scientific protocols and studies conducted to support premarket clearance
• Draft and track of regulatory submissions and facilitating communication between clients and FDA
• Representation of clients at meetings with federal regulators and facilitation of dialog on complex regulatory matters to achieve positive outcomes

About you
You will be an established commercially successful expert who can blend a deep scientific and regulatory understanding with exceptional interpersonal skills to deliver the sale of strategic advice and complex programs of work to our clients while building and leading sustainable and profitable practice.

Qualifications/Experience Includes:
• At least 10 + years’ relevant experience gained from contract research or consultancy position and a doctorate level degree.
• Known leader within field of expertise to attract opportunities and new client relationships
• Effectively communicates with clients and manages the client relationship
• Demonstrates excellent communication, organization, writing and editing skills
• 5+ years of experience preparing and submitting premarket submissions for medical devices such as 510(k)s, PMAs, or de novo petitions
• Excellent written and verbal communication skills and proven ability to develop and clearly communicate sound scientific arguments
• Proven ability to work independently or as a member of a multidisciplinary team
• Ability to manage multiple projects and track budgets

 

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