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Clinical And Regulatory Affairs Expert F/M

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Location: Saint Louis, United States
Position Type: Unfixed Term
Job Function: Regulatory Affairs

bioMérieux S.A.

Clinical And Regulatory Affairs Expert F/M

 

 

 

As part of the newly created CARAT (Clinical And Regulatory Affairs Team) Support Office, we are in search of a CARAT expert who will be part of an international team of about 15 people.

 

 

Main Missions:

 

- Play a project leader role for internal projects and as required specific bioMerieux projects led by CARAT

- Strongly contribute to management of internal and external communication for CARAT group: work closely with teams and managers to finetune the communication needs, contribute to development of communication tools

- Assist in the development of company clinical and regulatory policies and procedures that are compliant with applicable regulations, guidances and standards

- Participate to external trade associations (such as Medtech)

- Represent department in transversal company projects that require regulatory input and guidance (such as UDI, RECAST)

- Contribute to delivery of guidance on clinical and/or regulatory topics

 

 

Profile :

 

- Developped knowledge and understanding of clinical and regulatory requirements, more than 5 years experience in IVD/MD environment

- Developped knowledge of bioMerieux products (reagents/instruments/software)

- Project leader skills is a plus

- Strong communicator - capacity to challenge, influence and negotiate, at ease in an international environment

- fluent in English

 

Job based in France (Marcy) or USA (St Louis).

 

 

 

 

Working at bioMérieux means being involved long term with a pioneering, visionary and constantly growing company that allows its employees to live a stimulating and inspiring experience in a fulfilling work environment

Our internal mobility policy offers numerous opportunities for each of our 13 000 employees to blossom throughout their career, while respecting each employee’s individual talents as well as their personal and professional development.

At bioMérieux, over 200 professions - both scientific and non-scientific - offer our employees the opportunity to broaden their fields of expertise and develop cross-functional careers. We provide a rewarding experience in an international company that brings together talents from diverse backgrounds, thus fostering a daily aspiration to go beyond the limits.

Helping improve public health around in the world : our mission gives purpose to every profession practiced within the company.

bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity/GINA.

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