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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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Reporting Relationships:

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 Qualifications:

  • 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.

Preferred Qualifications:

  • 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;

Education:

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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