知名外资医疗器械公司
Regulatory Manager
医疗器械及设备
监管
广东
3-5年
本科
¥35K15薪
公司介绍
我们的客户是一家全球知名外资研产销一体化公司，业务稳健，平台大且能够长远发展，是一个可以长期稳定发展并能持续提升个人职业技能的机会。
职位描述
主要职责 Main Task
1. Regulation and standard management法规标准管理:
1.1 Define regulatory compliance strategy and procedures for the APAC Region (“the Region”), in coordination with the EMEA RA Manager and NALA RA Manager, based on existing or up-coming product-related regulations by tracking and managing new related laws/regulations and standards/norms
1.2 Drive the regional implementation of regulatory requirements
1.3 Staff training in RA, in coordination with EMEA RA Manager and NALA RA Manager
1.4 For the Region, act as the first contact point and provide regulatory guidance during the entire product life cycle.
2.Business process and product development compliance 商业过程和产品开发合规
2.1 Ensure that the necessary elements from an RA point of view are integrated in the business process to enable prompt approvals and to minimize risks
2.2 Participates in product design, safety strategies, test planning, product-releases, etc.
2.3 Advice Head of Group Quality Management and EHS and the Management Team in all product RA related matters for the Region
3.Product approval 产品注册上市
3.1 Responsible for clarification of regulations governing approvals in different markets in the Region, in close cooperation with local Quality Representatives, RA Managers, Conformity Representatives, and related officers and is point of contact for authorities (approvals etc.)
3.2 Assistance to the LPCR in the Region for product registration
3.3 Ensure the Local RA managers in the Region have the appropriate documentation to do the Market Registration approval
4.Authority relation and post-market activity compliance监管机构关系和上市后活动合规
4.1 Coordinate local competent authority requests
4.2 Act as the contact person for internal and external regulatory inquiries in the Region
4.3 Responsible for the coordination or escalation of critical incidents in the Region
4.4 Provides support for local Product Compliance Reps/Quality Managers in the Region with recall management, RA related complaints management and resulting measures
4.5 Support RA-related QMS audits and inspections.
4.6 Management & coordination of RA-related Customer enquiries in the Region
4.7 Support regional and global post-market surveillance activities and clinical evaluation
职位要求
工作经验/经历 Work Experience
1. Four years of professional experience in regulatory affairs.
2. Experience in medical device development
专业知识/技能 Knowledge And Skill
1. Sound understanding of the regulatory frameworks, Standards and Regulations in the key countries in the Region
2. A track record of success through appropriate technical skills, including product registration and definition of successful strategies for product registrations
3. Proven leadership abilities and a team-oriented perspective who finds the right balance between demand and support
4. Actively cultivates a network of productive relationships in an international matrix environment
5. Business fluent (written and spoken) in English; and strong command in technical writing; proficiency in an Asian language desirable.
6. Ability to absorb and impart information and communicate effectively, as well as convincing others on a factual basis, both verbally and written
7. Profound knowledge of national directives and ISO international standards interdependences
