Product Regulatory Specialist
hace 3 días
Product Regulatory Specialist
At SGS, we are seeking an experienced Product Regulatory Specialist to join our team of regulatory professionals. As an IVDR Product Assessor, you will play a crucial role in ensuring the compliance of in-vitro diagnostic medical devices with the European In Vitro Diagnostics Regulation (IVDR).
Your key responsibilities will include conducting technical file reviews against the EU In-vitro Diagnostics Regulation for Class A sterile, Class B and Class C devices. You will verify compliance of technical documentation submitted by manufacturers against the regulatory requirements and identify, document and seek to rectify instances where device technical files deviate from compliance.
You will also provide support for CE marking activities within SGS, contribute to the training and qualification of junior staff, and develop comprehensive training materials. Effective communication with team members, clients, and other stakeholders will be essential in minimizing regulatory risks associated with in vitro diagnostic device certification.
To be successful in this role, you will need to expand and keep up-to-date your knowledge of relevant technologies, regulations, international standards and best practice guidance documents.
Key Qualifications:
- At least 4 years of professional experience within the domain of healthcare products or in related activities.
- 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.
- 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.
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