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Since 2020, in a OneHealth spirit, we have expanded our field of application from molecular biology to medical biology to detect respiratory pathogens.

More recently, environmental biology has come to complete the applications of our activity in molecular biology.


For complete autonomy of our activity, we recruit in CDI our:


Regulatory Affairs Manager



MISSIONS:  The main tasks will be:

- Coordinate, and compile CE marking technical files following regulations

- Submit and follow CE marking files with the Notified Body

- Ensure that the in vitro diagnostic medical devices manufactured and distributed by the company comply with the regulatory requirements of the countries of sale

- Participate in the analysis of the impact of the changes produced on the regulatory authorizations obtained and classify these changes

- Make declarations to the competent authorities

- Be the reactovigilance correspondent

- Analyze reactovigilance cases, carry out reactovigilance declarations and corrective safety actions

- Carry out regulatory and normative monitoring

- Approve proofs of packaging items

- Approve the content of promotional materials

- Perform post-marketing surveillance

- Organize regulatory training

- Ensure the relationship with the Notified Body.


The Regulatory Affairs Manager will also have the following duties in Animal Health:

- Registration of regulated kits with the competent authorities in the target countries in the application of the registration strategy decided by the Sales Department

- Define and organize the tests to be carried out to allow the development of products according to the decisions of the Sales Department by:

          - Ensuring sample traceability
          - Respecting the product specifications
          - Participating in the development of new protocols
          - Drafting the necessary documents


The Regulatory Affairs Manager will also:

- Work in collaboration with the QHSE Manager and the Scientific Director

- Provide reporting to management


EXPERIENCE/KNOWLEDGE REQUIRED:

- First successful experience in DMDIV regulations

- Excellent writing, communication, and synthesis skills

- Fluent English


PROFILE:

- Initial Bac +5 training in Regulatory Affairs

- Bac +5 biology and additional training AR

- DE pharmacist

- ISO 13485 standard training


REQUIRED QUALITIES:

- Rigour, and compliance with protocols/procedures in place (ISO 9001)

- Responsiveness, and adaptability to changing priorities

- Work with different teams


TERMS:

- CDI starting in December 2022

- Status frame

- Gross monthly salary: €3,000 to €3,200 depending on training and experience

- Weekly schedule: 36.5 hours (including 1.5 hours of CPR) from Monday to Friday

- Location: Dardilly. Accessible by TCL from Vaise station.

- Occasional trips to France and abroad

- Benefits: Restaurant tickets, transport assistance (TCL), profit-sharing agreement


Applications (CV and cover letter) should be sent to blandine.vautrin@biosellal.com.