Senior Regulatory Affairs Specialist

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.