Regulatory 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 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 Regulatory Consultant, you will be responsible for supporting and maintaining TSG’s professional excellence in the medical device regulatory/technical service practice area.

The opportunity
We are actively seeking a regulatory consultant to support our medical device service offerings. You would report directly to, and work closely with, TSG’s Vice President and Principal, Medical Device Regulatory.

Responsibilities include but are not limited to:
• Provide technical and regulatory support for obtaining the premarket clearance of medical devices regulated by the United States Food and Drug Administration (FDA)
• Work with management to develop the appropriate regulatory strategies to ensure efficient premarket clearance for various types of medical devices and assist clients in implementing them
• Assist in the drafting of product development plans encompassing the scientific rationales and performance, biocompatibility, and shelf life studies necessary to obtain premarket clearance, in consultation with other subject matter experts (e.g. toxicologists, chemists, engineers) as required
• Work with the team to review and comment on scientific protocols and studies conducted to support premarket clearance
• Draft and track regulatory submissions and facilitating communication between clients and FDA
• Work with management to advise clients regarding compliance with FDA’s medical device requirements
• Participate and represent clients at meetings with federal regulators and facilitation of dialog on complex regulatory matters to achieve positive outcomes

About you
As a consultant based in the Washington, D.C. office will bring the ability to organize, coordinate and communicate across internal consulting teams, externally with clients and federal regulatory bodies. A strong customer service ethic and ability to multitask is vital for this role. You will present a positive “can-do” attitude and be a self-starter within a team of dedicated professionals.

Qualifications/Experience Includes:
• Experience in the medical device regulatory area
• 3+ years of experience preparing and submitting premarket submissions for medical devices such as 510(k)s, PMAs, or de novo petitions. Would be willing to train for someone with less experience.
• 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
• A science or engineering background is preferred but not essential

You will be offered a competitive salary and benefits package.


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