Regulatory Affairs Specialist - Medical Device (Remote - US)

Regulatory Affairs Specialist - Medical Device

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.

ICON's Medical Device & Diagnostics team is hiring a Regulatory Affairs Specialist! As the Regulatory Affairs Specialist, you will support the Regulatory Lead and Project teams with Medical Devices, In Vitro Diagnostics (IVDs), and Companion Diagnostics (CDx).

The Role:

• Apply scientific principles and maximize compliance to all aspects of regulatory activities undertaken.
• Undertake all required tasks requested to meet departmental and project goals, as appropriate.
• Participate in regulatory and/or clinical trial project teams. Assist with the preparation, writing and filing of appropriate regulatory agency pre-market submission, participates in regulatory agency meetings, assist with the preparation of additional data/information requested by regulatory agencies.
• Plan and track designated project activities including financial tracking.
• Initiate product research and regulatory intelligence in support of designated regulatory activities, as required, and provide information on regulatory requirements.
• Contribute to scientific and regulatory documents and communication letters to Regulatory Authorities in collaboration with Regulatory Project Lead or Functional Experts.
• Contribute to core regulatory submissions either alone or in collaboration with Functional Experts. Advise on regulatory aspects of project documentation.
• Contribute to regulatory submissions to support post-market administration/activities; e.g. preparation of variations to product approval either alone or in collaboration with Functional Experts. Support the regulatory assessment of proposed changes. Advise on regulatory aspects of post-market activities.
• Peer review, QA and/or checking, as appropriate of documents prepared by other professionals within ICON.
• Keep the relevant Regulatory Project Lead or designee informed of the progress of project activities at all times.
• Develop and maintain a current awareness of regulatory requirements through publications, seminars and appropriate training courses as deemed necessary.
• Liaise and work with colleagues from other departments, clients and Regulatory Authorities as required.
• Maintain an accurate record of the time associated with each activity.
• Other duties as assigned.

To be successful in the role, you will have:

• Minimum of a Bachelor's degree in Life Sciences or related field
• Demonstrable experience within regulatory affairs or comparable experience, including document preparation and/or writing, clinical trials, post-licensing activities and regulatory agency interaction.
• Demonstrable knowledge of marketing authorization application procedures
• Strong organizational skills, ability to manage multiple tasks and meticulous attention to detail.
• Excellent written and oral communication skills
• Good written and spoken English
• Strong technical writing and editing skills
• Ability to manage and prioritize multiple projects with strong attention to details
• Ability to understand technical topics and regulatory science
• Proficient in the use of Microsoft Office, electronic support systems for time keeping, document control, etc.
• Due to the nature of this position it may be required for the employee to travel. Therefore, depending on the employee's location, the employee may be required to possess a valid driver's license.

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.