Regulatory Affairs Specialist - Medical Device (Remote - US)

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

The Role:Responsible for providing advice and support to the project team for regulatory operations aspects of the projects.Manage and ensure maintenance of a positive and productive liaison with internal and external contacts (i.e. regulatory agencies, clients, co-workers, staff, etc.)Maintain a strong customer service management approach with clients.Lead project teams and advise departments on regulatory standards issues and strategiesDevelop, write, and implement standards and procedures related to regulatory operations.Identify client issues and develop alternative strategies for presentation to client consulting with other resources within organization as requiredParticipate actively in other business related projects (business opportunities, client specific issues, etc.) and planning.Client consultation and preparation of quotes and is responsible for achieving utilization goalsReview documents and advise clients on the adequacy and suitability of regulatory documentation, for example in relation to regulatory strategy, Investigator Brochures, Instructions for Use, clinical evidence submissions for clinical evaluations, post-market surveillance, Vigilance, Literature Reviews, Clinical Evaluation Reports, 510ks, PMA's, Licensing, Labeling, etc.

To be successful in the role, you will have:Minimum of 3 years experience of regulatory affairs within medical devicesExperience in global submissionsExperience in medical device/IVD global regulations, standardsGood knowledge of class 2 and 3 devices

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.