Masimo Corporation Senior Regulatory Affairs Manager (China) in Shanghai, China
Senior Regulatory Affairs Manager (China)
Position Location Shanghai, China
Job Code Posting 4760
Quantity Required 1
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This job reports to: Vice President or Director or Senior Manager, Regulatory Affairs. Reporting directly (or indirectly) to this position are the following job titles: Senior Regulatory Affairs and Regulatory Affairs Specialists.
Duties & Responsibilities:
Prepare and lead the regulatory team in the preparation and submission of regulatory applications to obtain approvals to commercially distribute the company’s medical device products;
Collaborate with key officials/team members at China certified testing laboratories to facilitate timely product testing.
Lead and mentor the regulatory team in preparing, updating and maintaining submission dossiers;
Lead in the selection, qualification, and maintenance/termination of service consultants ensuring compliance to internal company processes and requirements. Manage projects and services rendered by consultants.
Oversee the product related regulatory submission dossiers and the maintenance of market approvals;
Interact with country regulatory agencies on submissions inquires, additional document requests and/or provide technical clarifications to address agency concerns.
Assist in managing the maintenance of regulatory affairs files and distribute information as required to support key stakeholders/sales team;
Work with engineers on test protocols and test requirements to meet the requirements and guidance documents of regulatory health authorities and country regulatory agency;
Provide guidance to team members/consultants as needed regarding compliance to international/country specific standards (e.g., Electrical Safety, EMC, software);
Distribute/Share critical information/lessons learned on regulatory topics with Masimo Regulatory Asia counterparts to promote regulatory best practices.
Review of engineering, labeling, and manufacturing document release and changes, as requested;
Manage/Assess regulatory impact of product changes on commercialized products (product lifecycle management) maintaining compliance with regulatory requirements.
Assist in representing the Company before US and international regulatory authorities as needed;
Provide counsel, training, and interpretation of regulatory requirements to Company personnel;
Management of staff including:
Hire, promote, demote, reclassify or terminate employees
Write and conduct performance appraisals and disciplinary actions plans
Create training and employee development plans
Handle all departmental employee relations issues
Performs other duties or special projects as assigned;
Minimum & Preferred Qualifications and Experience:
Minimum 3 years of direct experience managing and training staff in a regulated industry
Minimum 5 years of direct experience in preparing domestic China, Taiwan, Hong Kong product submissions;
Experience in Quality Systems per ISO 13485;
Ability to work in a Project Team Environment;
Excellent ability to make strategic decisions;
Excellent ability to quickly learn and understand different type of technologies and concepts;
Excellent verbal and written communication skills;
Excellent prioritizing, organizational, and interpersonal skills;
A detail-oriented individual with a “can do” attitude and ability to lead in a team environment as well as individually contribute with minimal supervision;
Ability to work in a fast-paced environment with multiple tasks/projects;
Ability to effectively communicate in both Chinese and English verbally and in writing.
Regulatory experience in patient monitor systems, hospital-based products, software or electronic device products;
Experience with UL/ETL certification process;
Experience with EMC testing;
Experience interacting with regulatory bodies such as the Notified Body;
Bachelor’s degree is required, preferably in engineering or life sciences.
Graduate degree in technical discipline or business management is preferred.
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