Regulatory Affairs Specialist

Location: Castel Maggiore, Bologna, Italy

**JOB DESCRIPTION**
We seek to recruit a Regulatory Affairs Specialist responsible for managing activities associated with regulatory assessment of in vitro diagnostic products in compliance with (EU) 2017/746 (IVDR).

**DUTIES AND RESPONSIBILITIES**
- Be responsible for Regulatory function strategic planning oversight, initiative prioritization and coordination.
- Support project teams to obtain regulatory approval or clearance for company laboratory developed assay in compliance with (EU) 2017/746 (IVDR).
- Be responsible for the collection and maintenance of the technical documentation needed for the product registration by providing guidance to the team about the needed documentation to produce.
- Follow the evolution of MDCG Guidance for the interpretation of the IVDR requirements and guide the team in the correct implementation of the requirements.
- Be responsible for implementing or updating the Standard Operative Procedures of the Quality Management System needed for regulatory purposes.
- Provide technical review of data or reports for regulatory submission to assure scientific rigor, accuracy, and clarity of presentation.
- Manage audits with the Notified Body and in case of non-conformities menage the corrective actions implementation with the support of the team.
- Manage relations with the Competent Authorities and with the Notified Body.

**REQUIREMENTS**
- Master degree in Science or related fields (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology).
- Proven experience in successfully developing and implementing RA strategies for IVDs.
- Certified training course on IVD Regulation (IVDR).
- Certified training course on ISO 13485:2016.
- Knowledge of:

- Clinical evidence requirements for CE certification under IVDR.
- IVD products risk-based classification rules and subsequent procedures for CE Marking

registration of the product in EUDAMED database.
- Experience interfacing with local & international regulatory bodies.
- Fluent written and spoken English language.
- Proven experience with the following:

- ISO 17025: 2005 - General requirements for the competence of testing and calibration laboratories.
- ISO 15189:2012 - Medical laboratories - Requirements for quality and competence.
- ISO 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes.

Menarini Silicon Biosystems S.p.A. is committed to equal opportunity in the terms and conditions of employment for job applicants without regard to race, colour, religion, sex, sexual orientation, age, gender identity or gender expression, national origin.