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Staff Regulatory Affairs Specialist (hybrid)

This job posting is no longer active.

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

A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 44 countries and serve 160 countries with the support of a large distribution network. This includes our SLC site, formerly known as BioFire Diagnostics.

1 Primary Purpose and Overall Objective of the Job:
Develop regulatory strategy of similar and new products and execute regulatory processes as planned.

 

2 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.

 

3 Typical Studies-Experience, Skills and Qualifications:

 

3.1 Studies-Experience:

  • Bachelor's Degree in Science or Engineering 
  • 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.

 

3.2 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.

 

 

 

 

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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