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Job Profile Summary:

The Sr. Regulatory Affairs Business Manager is responsible for ensuring that all products meet regulatory standards and compliance requirements by coordinating and managing regulatory submissions, registrations, and approvals, conducting thorough risk assessments and implementing corrective actions as needed. The role monitors and influences regulatory and legislative changes, provides strategic advice to product development teams, influences product design and development to ensure compliance and oversees the preparation, review, and submission of regulatory documentation, maintaining accurate records. The role coordinates global regulatory business strategies, engages with senior management on cross-functional matters, and establishes adherence to budgets, schedules, and performance requirements while managing talent across the team.

Job Responsibilities:

Ensures all products meet regulatory standards and compliance requirements by coordinating and managing regulatory submissions, registrations, and approvals, ensuring thorough documentation and adherence to all relevant guidelines and standards.

Manages and guides the regulatory compliance team, establishing a competence matrix and ensuring the team effectively handles PDLM/MLD projects to maintain high regulatory standards and performance efficiency.

Conducts thorough risk assessments for regulatory compliance and implements corrective actions to address any identified issues, rejecting or escalating applications when they pose risks that cannot be resolved locally, mitigating potential risks and ensuring continual compliance with regulatory standards.

Monitors and influences regulatory and legislative changes, advocating for favorable policies and ensuring the company's interests are represented, staying ahead of industry trends and adjusting strategies accordingly.

Provides strategic advice and guidance to product development teams on regulatory requirements, influencing product design and expedites regulatory approvals for products in controllable situations to reduce time to market while ensuring all compliance requirements are met.

Oversees the preparation, review, and submission of regulatory documentation to ensure accuracy and completeness, maintaining records in compliance with regulatory standards, and facilitating smooth regulatory reviews and approvals.

Develops and delivers training programs to enhance the regulatory knowledge and awareness of internal teams, ensuring a culture of compliance throughout the organization and equipping staff with the latest regulatory insights and practices.

Coordinates the development and execution of global regulatory strategies, including CE Marking, clinical evaluations, and product registrations, ensuring successful market entry and compliance across regions, and managing cross-functional collaboration.

Engages in frequent interactions with senior management or executive levels regarding matters spanning multiple functional areas, divisions, and/or customers, providing expert insights and influencing strategic decisions.

Establishes and ensures adherence to budgets, schedules, work plans, and performance requirements to maintain operational efficiency and effectiveness, optimizing resource allocation and project timelines.

Offers strategic guidance on understanding and implementing standards and regulations, consults with product teams on transitioning to new requirements, and represents the organization on technical committees to influence the development of industry standards.

Manages talent across the team, driving employee selection, performance management, compensation management, and career development, ensuring effective operational management and fostering a high-performing regulatory team.


You are a part of


RA Team You will base in Suzhou.


To succeed in this role, you should have the following skills and experience
61 BS in engineering discipline or equivalent education, experience, training.
61 At least 8 years regulatory experience in medical device industry.
61 Experience in China local manufactured or local developed products will be a plus.
61 Strong understanding of China FDA and other major international regulations
61 Be able to manage multiple tasks and perform with accuracy and a high attention to detail
61 Requires strong written, oral and interpersonal skills to be able to effectively compose agency
submissions, interface interdepartmentally and complete assignments with minimal supervision.
61 Proficient in English communication including reading, writing, speaking and listening.