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Regulatory Affairs Specialist

Date: Dec 31, 2020

Location: Saint Louis, MISSOURI, US

Company: bioMérieux

A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux provides diagnostic solutions that detect disease and contamination to improve patient health and ensure consumer safety. bioMérieux’s global headquarters is located in Marcy L’Étoile, France, and we have more than 11,200 team members in 43 countries. With our distributor network, we serve more than 160 countries. bioMérieux, Inc., our Americas division, has more than 4,000 team members across 12 sites or subsidiaries. Our Americas headquarters is in Durham, NC, with nearly 1,200 team members. bioMérieux, Inc. sponsors public health initiatives and partnerships to address antimicrobial resistance, sepsis awareness, food safety, and consumer health. Our passionate team members recognize the power of diagnostics and rally behind our mission to help save lives.

 

Position Summary:

Develop regulatory strategy of similar and new products and execute regulatory processes as planned.


Main Accountabilities:

  • Conduct research on regulatory changes and developments and on application requirements and process
  • Assist in the development and review of procedures
  • Advise responsible personnel on regulatory requirements and develop options with recommendations; develop product regulatory strategy; assess continuously project output and impact on regulatory strategy and launch date
  • Validate product labels, instructions for use, advertising and promotional materials
  • Compile and organize content of regulatory applications and files; assess acceptability and completeness of documents; identify unmet needs and provide feedback; ensure filing and timely retrieval
  • Interact with regulatory authorities and execute regulatory processes; provide feedback on application review progress and questions; coordinate and review answers to questions
  • Report on issues


Studies and Experience:

  • Knowledge of regulatory requirements, guidance documents and processes (local/regional) with more than 5 years of practice in the field of IVD/MD in an international environment
  • Basic knowledge of QMS requirements (QSR and ISO 13485 and/or local GMP if appropriate) with developed knowledge of design and change controls
  • Familiar with product profiles and technology, with company organization and processes
  • Familiar with local regulatory agency organization
  • Participation in local professional, trade organizations

 

Skills and Qualifications:

  • Analyze, understand regulatory requirements and identify solutions; provide directions for proper implementation
  • Routine problem solving
  • Develop rationale and justify position
  • Communicate to internal stakeholders and regulatory agencies or their representatives
  • Can work in an international environment

 

Joining bioMérieux, is choosing to join an innovative company with a long term vision, committed to the service of public health and carried out with a humanistic corporate culture. Our Group offers numerous possibilities: so come and join the 11,200 bioMérieux team members who already identify with these values!

 

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

 

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