招聘人数：1-2人
到岗时间：不限
年龄要求：不限
婚况要求：婚姻状况
语言要求：
英语
The Regulatory Director is responsible to ensure SSI China compliance to FDA and other international regulations. Prepare and submit regulatory dossiers to support international regulatory registrations and FDA submissions which may include device 510(k), IDEs, etc. Provide regulatory supervision on post-market product changes to maintain. Develops and implements strategies with the goal of approval of regulatory submission. Also, responsible for the overall planning and direction of clinical regulatory activities.
Primary responsibilities
?Manage all aspects of all ongoing and new regulatory submissions, both U.S. (e.g., PMA, IDE, 510(k), PMA Annual Reports, etc.), and international (e.g., CE Technical Files, Design Dossiers, APAC, etc.).
?Create regulatory dossiers, i.e. technical files or Design Dossier for CE Marking.
?Monitor and ensure appropriate ongoing Company-wide regulatory compliance with applicable GMP/ISO/EN standards and other pertinent standards. Review and assist in the development of Company Quality Manual and standards.
?Provide regulatory support for risk management activities and clinical evaluation
?Effectively manages and prepares regulatory documents and submissions to ensure timely approvals of products and processes in accordance with business strategies and marketing plans.
?Plan, schedule and direct activities and programs through regulatory staff.
?Negotiate with outside agencies as needed to resolve key regulatory issues.
?Obtain and manage foreign registrations; partner with appropriate representatives to locally confirm and file foreign regulatory requirements
?Prepare and provide responses to regulatory agencies regarding product information or issues
?Submit supplements and amendments to update registered product information.
?Develop Regulatory Strategies for new or modified products and assist on project planning.
?Monitor and update national and international registration requirements through reviews of publications, seminars, and direct communication with outside regulatory personnel.
?Hire, train, and supervise regulatory staff.
?Handle budget requirements and monitor project and program costs.
?Review, evaluate, and compile files and reports for submission.
?Coordinate and prepare document packages for regulatory submissions ensuring compliance with the regulatory directives.
?Provide guidance by establishing goals for the regulatory team and conduct regular performance reviews for all team members to ensure achievement of goals.
?Establish framework and develop teams for both Internal and External Audits.
?Making relationships with Hospitals, Surgeons and organizations to arrange for clinical trials and Pre-market launches.
Qualifications & Experience
?Bachelor’s Degree in Sciences, Engineering, Technical or equivalent. MS or MBA preferred.
?Minimum of 12 years of experience needed with 5 years of regulatory affairs working experience, mainly for medical devices.
?Must have knowledge of U.S. and/or European/International regulations and standards
?Demonstrated aptitude preparing and submitting government submissions is required.
?Prior interaction with the FDA, Notified Bodies and other worldwide agencies is mandatory.
?Experience working with cross-functional teams is required.
?Ability to write, proofread and check documents for accuracy is required.
?Must have extensive experience in preparing all types of FDA/ISO/CE submissions and documentation.
年薪31.5-37万
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