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 senior-level consultant to help build 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)

• Help develop the appropriate regulatory strategies to ensure efficient premarket clearance for various types of medical devices and assist clients in implementing them

• Draft 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

• Review and comment on scientific protocols and studies conducted to support premarket clearance

• Draft and track of regulatory submissions and facilitating communication between clients and FDA

• Advise clients regarding compliance with FDA’s medical device requirements

• 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 market strategic advice and complex programs of work to our clients while building and leading sustainable and profitable practice.

Qualifications/Experience Includes:

• Strong experience in medical device regulatory

• 3+ 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

• A science or engineering background is preferred but not essential

Benefits

You will be offered a competitive salary and benefits package.

 

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