Senior Regulatory Affairs Specialist

Your New Career Opportunity

This is a great opportunity to join a respected healthcare brand.

About the Company

• Over 107,000 employees worldwide
• Selling in over 160+ countries
• 130+ years in business
• Market leader in 8 categories
• Fortune's Most Admired Companies Award 

Your Responsibilities

This position performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product market entry.

Job Duties include followings:

• Prepares robust regulatory applications (either for FDA or for international regulatory agencies) to achieve departmental and organizational objectives. 
• Creates, reviews and approves engineering changes.
• Acts as a core team member providing review and analysis of applicable regulatory guidelines and project regulatory assessments as needed.
• Reviews and evaluates communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other worldwide regulatory agencies to various international affiliates.
• Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into a regulatory submission database and file systems. Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel.
• May interface directly with FDA and other regulatory agencies.
• Reviews protocols and reports to support regulatory submissions.
• Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Performs other related duties and responsibilities, on occasion, as assigned.

The Benefits You Will Receive

• Top-tier company
• Central Tokyo office
• Work for an international and known brand

Benefits

Speak English	Central Tokyo	Top Tier	International  Environment