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REGULATORY SERVICES GROUP

MDCI has the following open positions in our Regulatory Services Group, which supports clients through the development and implementation of regulatory strategies to gain marketing authorization for medical devices in the U.S. and internationally.

SENIOR REGULATORY STAFF CONSULTANT

Support clients through the development and implementation of FDA and OUS regulatory strategies to gain marketing authorization for medical devices and diagnostics. Reports to the Vice President of Regulatory Services & Business Development, with the following principle responsibilities:

• Assists, advises, and guides global clients in defining requirements, addressing issues, and negotiating clearance/approval with FDA and OUS regulatory bodies for the introduction and on-going marketing of medical devices and IVDs. Develops regulatory strategies for new and innovative medical devices.
• Functions as project leader and/or team member on large or complex projects
• Provides internal direction, support and advice to junior regulatory staff to develop appropriate approaches to achieve FDA and OUS device approval/clearance and address client questions and concerns
• Directs and/or conducts required literature searches and background research. Writes, edits, and prepares regulatory submissions, including pre-IDE, IDE, PMA, 510(k), and other formal and informal communications with FDA and international regulatory bodies as required. Attends pre-IDE meetings and other meetings as needed.
• Provides ongoing client communication to maintain awareness of project progress, manage ongoing concerns, address questions, and maintain budgets
• Acts as primary point of contact with regulatory bodies on behalf of clients
• Assists clinical services and quality assurance staff by providing regulatory advice as needed
• Develops and/or assists clinical services staff in the development of investigational plans/protocols
• Attends trade shows and professional society meetings both for continuing professional development and to support business development/networking with potential and existing clients
• Presents and speaks at industry events, professional meetings, webinars, etc. to support business development efforts. Publishes written and electronic articles, blog posts, and other materials as needed. Prepares cost proposals and budget estimates for new and existing clients as needed

Qualified candidates will have a minimum of 10 years progressive medical device /IVD regulatory affairs experience. Specific orthopedic and/or cardiovascular experience preferred. Demonstrated experience and expertise authoring 510(k)s and other regulatory submissions/documentation. Good working knowledge of all aspects of Food and Drug law and relevant OUS medical device regulations, B.S. in engineering, sciences, or medical field required, advanced degree (MS, PhD, MD) desired; RAC preferred. Excellent oral/written communication skills and attention to detail required; prior consulting experience is a plus.

At MDCI each individual makes a valuable contribution to our clients' successes. You will work with bright, highly motivated people and be part of a collaborative team that leverages the skills and experience of all employees. You will work in an environment that values and supports quality of both work and life.

We offer a competitive salary and benefits package that includes matching 401k, profit sharing, medical insurance, dental insurance, life insurance, disability benefits, paid time off, paid company holidays and schedule flexibility.MDCI is an equal opportunity employer.

To apply, send a letter of interest and curriculum vitae/resume to Lisa Fuller, Human Resources Manager at fuller@mdci.com