Regulatory Affairs Specialist

Come and join us in a highly collaborative environment where we fight cancer together 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.

The role offers the responsibility for the full compliance and regulatory process in Germany which will require continuous improvements to ensure products meet customer expectations. Proactively taking the lead in a changing regulatory environment to support the business to prevent 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.
- Managing projects to ensure they are delivered on time and performance is achieved at a high standard.
- Secure product registrations in accordance with regulations.
- Actively engage with trade organizations for influencing the regulation process at the EU Commission level to promote Agilent interests
- Internally be the point of contact to provide support and clarification of regulatory requirements and respond in a timely manner.
- A university degree in a relevant field combined with regulatory experience. If you hold a certification in a niche relevant area, that is considered a plus.
- Experience in product certification, medical device/IVD registration, and implementation of regulations (chemical, biological, safety, environmental).
- Solid understanding of IVD regulation, REACH, SVHC, and other EU legislation
- Good analytical mentality, eye for business, and ability to translate regulatory requirements into business-relevant targets and activities.
- Fluent verbal and written skills in German, fluent in English

**What we offer you**:

- An independent job in collaboration with good colleagues, in a growth-orientated organization
- We will make sure you get all the **training and development opportunities** you need to become the best in your field
- A true commitment to work/life balance

Agilent offers **core global benefits** to all staff - but in addition to these, the **business offers** Agilent Result Bonus, Stock Purchase Plan, Life Insurance, Pension, Healthcare, Employee Assistance Program, Holiday, and Company activities.

**About Us**

We are committed to making Agilent the best place to work for everyone by providing a truly inclusive work experience. Together, through collaboration, as One Agilent, we are better able to deliver trusted answers to our customer’s critical questions because we know there is work to be done.