1 Strong written and oral communication skills are essential, as is the ability to work cross-culturally.
2 Strong skills with MS-Office software, including MS-Access and/or MS-Excel are also necessary.
3 Ability to work in small team environment, but also self-starter with ability to work independently.
4 Ability to work on problems of diverse scope where analysis of a situation or data requires evaluation of various factors.
5 Must be able to meet deadlines and be detail oriented. Good planning and organization skills are essential.
6 Strong critical thinking and problem solving skills.
Regulatory Affairs Specialist: Minimum three (3) years experience working at an MNC on regulatory affairs marketing medical devices or pharmaceuticals, with preference given to regulatory affairs experience. Significant experience working internationally would be very helpful in this position.
职位描述:
Identify and keep current with their Chinese SDFA and MOH and other Chinese governmental bodies ‘s registration/approval and ongoing compliance requirements for marketing of STERIS products in China identified by STERIS management.
Provide advice and information on Chinese SFDA and MOH requirements to new product development teams and to STERIS management to assist with project planning and budgeting.
Prepare product registration documents for submission to meet the identified Chinese specific requirements to obtain marketing approval.
Work with STERIS International staff and STERIS dealers to assure the registration process is handled effectively. Respond in a timely manner to questions raised by Chinese SFDA and MOH and other Chinese governmental bodies, STERIS dealers and STERIS staff during the submission preparation and review process.
Communicate on the Chinese registration and compliance requirements to STERIS’ Regulatory Affairs, Quality Systems and other departments’ staffs as changes occur or as needs are identified so that these requirements can be incorporated into STERIS products and systems to facilitate marketing of STERIS products in international markets.
Maintain Chinese regulatory files and databases to ensure prompt and accurate access to company regulatory information and to provide regular reports to management concerning current, pending, and future approvals to management.
Responsible to manage and facilitate the warehouse and service room quality system audits that are performed by SFDA; including review of workpapers and objective evidence, developing corrective actions, reporting and tracking the resolution of observations noted during the audit;
Responsible for the management and execution of action plan tracking and follow-up of all audit observations noted during site-level quality system audits, external q audits, notified body and regulatory agency audits; including periodic updates from management to evaluate the status of the corrective action, obtaining objective evidence that the corrective action has been fully completed and reporting to Regulatory Affairs management on the overall status of corrective actions;
Provide the Chinese staff the training as needed on Chinese requirements and procedures and other international standard, practice, and policy update.
Help the service team with product regulatory testing and recall as needed.
Work with STERIS Contract Administration and Legal Departments in regard to the dealer contracts, Letter of Authorization, and other essential document to comply with the Legal and RA requirement
Provide regulatory information to STERIS China staff to support sales tenders and product registration purposes.
