Regulatory Affairs Specialist – Software Medical Device
ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.
With our patients at the center 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 Strategic Regulatory Services team is hiring a Regulatory Affairs Specialist! The Regulatory Specialist will be responsible for implementation and compliance for medical device regulatory processes applicable to ICON’s Care Innovations’ medical device products, which are classified as software as a medical device. The Specialist will participate in all related inspections and audits from regulatory agencies and customers. Prior regulatory experience with the medical device product lifecycle is required (design, development, verification, validation, manufacturing, distribution, support and end of life). A thorough working knowledge of US and EU medical device quality regulations and standards is required (FDA 21 CFR, EU MDRISO 13485. Experience with software as a medical device also preferred. Ability to successfully maintain regulatory compliance with individuals across organizations is essential.
The Role:
- Interact with regulatory agencies in the US, EU and other applicable countries as required.
- Maintain country establishment registrations and device listings in the US, Singapore, and other countries as required
- Develop/maintain appropriate regulatory strategy, regulatory processes, and product regulatory plan for ICON’s Care Innovations’ medical device products and other customer products where Care Innovations is the device manufacturer of record.
- Participate as part of the Care Innovations medical device team
- Maintain compliance to applicable regulations and standards as they evolve and determine changes to quality systems requirements as a result of these changes
- Partner closely with the Quality System Manager to review and approve product lifecycle evidence documents and other consulting as required
- 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
- 3 years’ experience with a medical device manufacturing company.
- Preferably at least 1 year with software as a medical device.
- Any experience with mobile applications is a plus.
Ability to work effectively in a highly distributed virtual team. - 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.
