Ivdr Product Assessor

1 month ago

Mumbai Maharashtra, India SGS Full time

**Company Description**
We are SGS - the world's leading **testing, inspection and certification** company. We are recognized as the global benchmark for **sustainability, quality and integrity**. Our 99,600 employees operate a network of **2,60**0 offices and laboratories**, working together to enable a better, safer and more interconnected world.

Our **Innovation Factory** promotes and develops digital innovation initiatives across SGS; we deliver solutions to the business at scale and speed. Our mission is to create a better, safer and connected world by supporting, improving or augmenting our physical operations with digital technologies.

As an **IVDR Product Assessor**, you will use your skills as an expert in **clinical diagnostic technologies** to ensure that patients across Europe have access to safe and effective diagnostic tests. Join our rapidly growing team of regulatory professionals in helping the European healthcare ecosystem navigate the challenging transition to the new **European In Vitro Diagnostics Regulation.**

**Key Responsibilities**:

- ** Conduct technical file reviews** against the **EU In-vitro Diagnostics Regulation** for **Class A sterile, Class B and Class C** devices within a defined timeframe, by verifying compliance of technical documentation submitted by manufacturers against the regulatory requirements.
- Identify, document and seek to rectify instances where device technical files deviate from compliance with applicable requirements under the **IVDR.**:

- Provide support for **CE marking activities** within SGS, contribute to the **training and qualification of junior staf**f, and develop comprehensive training materials.
- Communicate effectively with team members, clients, and other stakeholders regarding **product assessments**, working diligently to minimize regulatory risks associated with **in vitro diagnostic device certification**.
- Expand and keep up-to-date your knowledge of relevant **technologies, regulations, international standards** and best practice guidance documents.

**Qualifications**
- At least **4 years of professional experience** within the domain of healthcare products or in related activities. This may include for example roles in design and development, manufacturing, auditing, relevant academic research, or work in a clinical setting.
- Among these, a minimum of **2 years** should involve direct engagement in the **design, manufacture, testing or utilization of specific in-vitro diagnostic devices and technologies**, or relevant scientific research
- Knowledge encompassing a range of **IVR/IVS/IVP/IVD competence codes** for IVDR, as defined in Commission implementing regulation (EU) 2017/2185
- ** Degree **or equivalent qualification in a relevant technical discipline such as **medicine, engineering, biomedical science, microbiology or biochemistry.**:

- ** Proficient communication skills** using modern electronic platforms.
- Strong **written English skills**, as reports will be reviewed and queried in English.
- Demonstrated skills in **independent learning.**

**Desirable Skills**:

- Direct experience with **medical device development life cycle processes**, regulatory submissions and relevant standards such as **ISO 13485 and ISO 14971.**:

- Experience with **clinical studies and clinical performance evaluation** of in-vitro diagnostic devices.
- A broad base of experience covering a variety of different d**iagnostic assay types and technologies.**:

- Prior experience in conducting **product technical documentation assessments** for another **Conformity Assessment Body / Notified Body** (technical file reviewer or equivalent role) would be considered advantageous.

**Additional Information** Why SGS?**
- Join a globally r**ecognized and stable company, a leader in the Testing, Inspection, and Certification (TIC) industry.**:

- Enjoy a **flexible schedule and a** **fully remote work model.**:

- Access SGS University and Campus for continuous learning options.
- Thrive in a **multinational environmen**t, collaborating with colleagues from multiple continents.
- Benefit from our **comprehensive benefits platform.

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