RA Specialist

bioMérieux Japan Ltd.

RA Specialist

Main Accountabilities:

• Conduct research on regulatory changes and developments and on application requirements and process,
• Assist in the development and review of procedures, Assist in the execution of regulatory processes and interactions with regulatory agencies.
• 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.
• Made and Updated package insert / label

 Studies-Experience:(Preferable)

• 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 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.

Working at bioMérieux means being involved long term with a pioneering, visionary and constantly growing company that allows its employees to live a stimulating and inspiring experience in a fulfilling work environment

Our internal mobility policy offers numerous opportunities for each of our 13 000 employees to blossom throughout their career, while respecting each employee’s individual talents as well as their personal and professional development.

At bioMérieux, over 200 professions - both scientific and non-scientific - offer our employees the opportunity to broaden their fields of expertise and develop cross-functional careers. We provide a rewarding experience in an international company that brings together talents from diverse backgrounds, thus fostering a daily aspiration to go beyond the limits.

Helping improve public health around in the world : our mission gives purpose to every profession practiced within the company.

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