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Regulatory Affairs Specialist 2

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

A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux provides diagnostic solutions which determine the source of disease and contamination to improve patient health and ensure consumer safety.

In North America we have more than 5,000 team members across 11 sites or subsidiaries, including Salt Lake City-based BioFire Diagnostics and one subsidiary in Montreal, Canada.


Come and join a family-owned global company with a long-term vision, and a human-centered culture.

 

1 Primary Purpose and Overall Objective of the Job:

Develop regulatory strategy of similar products and ensure on time availability of complete regulatory application and files.

 

2 Main Accountabilities:

  • Understand, investigate regulatory history of similar products in order to assess regulatory implications for new products or change to existing products,
  • Stay abreast of regulatory changes and of application requirements and processes,
  • Develop product regulatory strategy based on history of similar products with considerations to recent changes in requirements and propose solutions to meet them,
  • Validate product labels, instructions for use, advertising and promotional materials,
  • Compile regulatory applications and files following existing procedures and documents; organize content; check regulatory applications and files for completeness and provide feedback; ensure filing and timely retrieval,
  • Assist in the execution of regulatory processes and interactions with regulatory agencies.

 

3 Typical Studies-Experience, Skills and Qualifications:

3.1 Studies-Experience:

- Bachelor’s degree in Science or engineering,

- Knowledge of MD/IVDMD regulatory requirements, processes and submission types (local/regional).

3.2 Skills and Qualifications:

- Research information and data,

- Analyze and understand technical and scientific documents,

- Attentive to details and to consistency,

- Communication with internal stakeholders verbally and in writing,

- Can work in an international environment.

 

 

BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).

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