The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
The Regulatory Affairs Specialist will provide regulatory guidance to study sponsors and IVD medical device manufacturers. You will be responsible for the overall planning and direction of clinical regulatory activities. In addition, you will develop and implement strategies in a collaborative environment between colleagues and clients with the goal of successful regulatory submissions.
Lead project teams in support of Clients’ Regulatory and Clinical goals with the aim of bringing their products to market.
Development, compilation, review and submission of U.S. Food and Drug Administration (FDA) Pre-Submission Meeting Submissions.
Development, compilation, review and submission of Regulatory Filings such as FDA 510(k), de novo and PMA submissions, Health Canada Licensure, EU Technical Files, etc. based on experience, regulations, and guidance available from regulatory bodies.
Interaction with regulatory agencies and Sponsors throughout the submission and review processes.
Assist in the creation of Clinical and Analytical Study Protocols, Informed Consent Forms (ICFs), Study Database, and Data Collection Forms in conjunction with project team members.
Assist clients in identifying and contracting with potential Clinical Trial Sites and/or Reference Laboratories.
Assist with Institutional Review Board (IRB) submissions.
Implementation of regulatory processes as they relate to company procedures, clinical studies, testing, and documentation and ensure that they are communicated through company policies and procedures.
Understanding of U.S. Food and Drug Administration (FDA) laws and guidances.
Understanding of Health Canada Licensing Requirements and the EU IVDR.
Understanding of IRB guidelines.
Ability to interpret study protocols, internal procedures, and Standards and Guidance Documents applicable to medical devices.
Computer skills including proficiency in use of Microsoft Word, Excel, Outlook, and PowerPoint.
Strong written and verbal communication skills including good command of English language.
Excellent organizational and problem-solving skills.
Effective time management skills.
Attention to detail and accuracy in work.
Ability to manage competing priorities without compromising quality.
Effective mentoring and training skills.
Ability to establish and maintain effective collaborative relationships with coworkers, managers, and clients.
Bachelor's degree in a health care or other scientific discipline or educational equivalent.
5-10 years Regulatory Affair Activities, with at least 2 years’ experience working with IVD devices.
10% Travel including local, within the U.S and outside of the US. Travel may include:
For over 30 years, MDC has helped innovators and entrepreneurs bring in vitro diagnostics (IVD) and medical devices to market and impact the lives of millions of patients around the world, every year. Our mission is to continue to support these innovators by applying our expertise in Regulatory Affairs, Quality Systems, Training, and other consulting services to help them launch new advances that promote and protect our global and local communities’ health. Learn more at www.mdcassoc.com.
By joining MDC you will experience opportunities to grow your skillset and advance your career in a culture where we value everyone, and where your success has a direct impact on the company and the industry. Take the next step to explore an opportunity with MDC by applying for this position.