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Senior Regulatory Affairs Specialist

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

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 as related to Chinese regulations,
  • Assist in the development and review of procedures in association with registration activities for the Chinese market,
  • 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 for the Chinese market.
  • 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 for the Chinese market,
  • Interact with the bMx Chinese subsidiary 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:

  • Knowledge of regulatory requirements, guidance documents and processes (for international regions) 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 as related to instrument systems, software, and reagents.
  • Familiar with local regulatory agency organization in China,
  • 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,
  • Have a technical understanding of instrument, software, & reagent products, and clearly explain technology in simple terms,
  • Ability to speak Chinese is desired but not required.

 

 

 

 

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