Regulatory Affairs Specialist (IVD / Medical Device) at Biomerieux, Inc in St. Louis, Missouri

Posted in Other 20 days ago.

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Job Description:

A world leader in the field of in vitro diagnostics for over 50 years, bioMérieux conceives, develops, produces and markets diagnostics solutions (systems, reagents, software and services) intended for clinical and industrial applications, which determine the origin of a disease or a contamination to improve the health of patients and insure consumer safety.

bioMérieux is present in over 150 countries through 43 subsidiaries and a large network of distributors. More than 90% of our sales are done internationally. Its corporate headquarters are located in Marcy l'Etoile, near Lyon, in France.

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.

We look for candidates whose motivation is to invest in themselves, in the projects of the future, and to participate in a collective adventure led by a pioneering spirit.

We have the commitment to offer our collaborators a working environment which encourages team spirit, with priority given to training and development with international career opportunities.

Our Group offers numerous possibilities: so come and join the 10,000 bioMérieux employees who have already identified with these values!

As a Regulatory Affairs Specialist, IVD / Medical Device candidates must (at a minimum),
  • Develop regulatory strategy of similar and new products and execute regulatory processes as planned,
  • Must have IVD / Medical Device experience,
  • 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,
  • Continuously assess project output and impact on regulatory strategy and launch dates,
  • 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,

  • Support international product registrations by providing the required documentation and deliverables necessary for competent authority approvals,
  • Interact with regulatory authorities and execute regulatory processes; provide feedback on application review progress and questions; coordinate and review answers to questions.



Qualifications:

  • Bachelor's Degree required.
  • Knowledge of regulatory requirements, guidance documents, and processes (local/regional).
  • A minimum 2 - 5 years of practice in the field of IVD Regulatory Affairs Medical Devices in an international environment.
  • Experience with compiling technical files and regulatory submissions to FDA and/or international regulatory agencies.
  • Experience reviewing & approving product labeling.
  • Experience with change control impact assessments, and knowledge of regulations and QSRs.
    • 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.
    • Familiar with local regulatory agency organization.
    • Participation in local professional, trade organizations.


Skills and Qualifications:
  • Ability to analyze & understand regulatory requirements, identify solutions, and provide directions for proper implementation.
  • Routine problem solving.
  • Develop rationales and justify the position.
  • Communicate to internal stakeholders and regulatory agencies or their representatives.
  • Good organization & communication skills.
  • Ability to work in an international environment.

Preferred:
  • Chinese language skills - ( Mandarin)
  • Strong understanding of Chinese culture, and work environment.
bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation