RA Supervisor-上海

Responsibilities：

• Establish/execute a thorough submission plan for each assignment within the timeline agreed by stakeholders;
• Work with diversified team to develop and execute regulatory strategy for complex local manufacture products and maintain existing licenses;
• Interact with CFDA/Provincial FDA on registration/manufacturing regulation requirements and monitor changes to requirements.
• Interact with manager as required by specific issues, milestones, or status changes.
• Manage the regulatory review of labeling, promotional materials, technical documents, clinical protocols, and clinical reports for products that are under his/her responsibilities.
• Ensure compliance with China regulatory requirements from pre-market perspective, including but not limited to change management, Chinese labeling requirements, etc..
• Monitors regulatory and standards developments affecting ** product he/she is responsible for, identifies and recommends committees that ** should be part of.

Required：

• Ability to communicate(oral/written) and interact effectively across all levels, disciplines, functions, and regions, particularly with regulators. Independently write reports/documents for distribution within division.
• Recognizes potential problems, including situations that include ambiguity, by actively reviewing and analyzing internal and external factors. Assesses potential impact and/or applicability to other related areas.
• Ability to confidently deal with ambiguous issues and provide input towards suitable actions.
• Demonstrated success in preparing, filing, and completing(including negotiations) regulatory submissions/dossiers/approvals with CFDA/CE authority.
• Experienced in meeting with, making presentations to, and negotiating with regulators, including complex or sensitive issues.
• Minimum 5 years working experience in medical device regulatory affairs, experience in infusion products will be a plus.
• Interpret subjective and complex aspects of specific regulations and has general understanding of multiple sets of associated regulations.
• Demonstrate in-depth understanding of advanced technical/scientific principles that relate to multiple, diverse, and or complex product lines or manufacturing processes.
• Independently manage and monitor multiple complex and diverse short term and long-term projects without direct supervision. Interact with manager as required by specific issues, milestones, or status changes. Maintains a “focused urgency” as required.
• Good communication skills, able to work under pressure, delivery orientated, willing to travel.