Senior Regulatory Affairs Specialist (IVD/ Medical Devices)
- Experience Level
- Experienced (non-manager)
You will be part of our Clinical & Diagnostics group and be exposed to innovative IVD products across different regulatory classifications including hardware, software and immunochemistry technologies.
We have a fantastic opportunity for an experienced Senior Regulatory Affairs Specialist who wants ownership and accountability in their work. To succeed, the ideal candidate will have the knowledge and experience within IVD/Medical devices, able to drive and handle projects and possess an analytical and critical mentality. In addition, the capability to collaborate cross-functionally as well as working independently, and able to influence to ultimately to handle issues and get results without compromising quality.
The role offers the responsibility for the whole compliance and regulation process in the UK, which will require continuous improvements to ensure products meets customer expectations post-Brexit. Proactively taking the lead in a changing regulatory environment to support the business to prevents barriers to trade and mitigate areas of risk, or matters of product safety and reporting for medical equipment products.
Your areas of responsibility will include:
- Identify and manage regulatory requirements for new and existing products and for any changes to ensure effective and fast product approvals post-Brexit.
- Managing projects to ensure they are delivered on time and performance are achieved at a high standard.
- Secure product registrations in accordance with regulations.
- Compile and review documentation for regulatory submissions, technical files, labelling for products, marketing/promotional materials for accuracy and maintain registration dossiers.
- Be the point of contact to provide support and clarification of regulatory requirements and respond in a timely manner.
- Communicate and provide training regarding the Regulatory Requirements in the UK to ensure compliance.
Knowledge, skills, and abilities needed to succeed in this role
- A university degree in a relevant field (including, but not limited to: biochemistry/engineer/law), combined with regulatory experience. If, additionally, you hold a certification in a specialised relevant area, that is considered a plus.
- Relevant track-record in Regulatory Affairs, preferably in IVD analytical and/or medical devices.
- Experience in product certification, medical device/IVD registration and implementation of regulations (chemical, biological, safety, environmental).
- Skilled in working with internal/ external customers, suppliers, and regulators.
- Knowledge of environmental regulations for applied EU markets.
- Understanding of international IVD regulations and UK requirements.
- Good analytical mentality, eye for business and ability to translate regulatory requirements into business relevant targets and activities.
What we offer you:
We will make sure you get all the training and development opportunities to become the best in your field.
Agilent offers core global benefits to all staff - but in addition to these, the UK business offers:
- Agilent Result Bonus
- Stock Purchase Plan
- Life Insurance
- Employee Assistance Program
- Company activities
Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek so they can do what they do best: improve the world around us. Information about Agilent is available at www.agilent.com.
Agilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws.