北京招聘

Main Tasks

· Collaborate with RA team to develop and implements RA strategy for global products registration in China, esp to communicate with testing lab on type testing support and product technical facilitation with Chinese authority & global team on product compliance to ensure submission and approval in line with biz plan to enable biz growth

· Advocate insights for specific emerging standard/technical guidance/regulatory requirement to RA team and stakeholder, collaborate with team to build and execute relevant RA process/WI to ensure compliance

· Communicate standard/technical guidance changes to global RA/CA in a timely manner, and provide insights in meetings and complying with new requirements for projects under assigned team

· Enhance and maintain good relationship with Chinese authorizes to facilitate review and approval effectively, take initiatives to work closely with standard committees/relevant parties to advise comments as key opinion leader in draft stage on behalf of company from technical perspective

· Leverage internal and external resources for RA strategy & plan in meeting registration requirements and advice regulatory requirements during product design stage proactively.

· Additional tasks as assigned by RA function head

· This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including knowledge of all standards, government occupational health and environmental regulations and statutes related to the site).

Requirements

· A Master/Bachelor’s Degree in medical/science/Engineering

· 5+ years working experience in the medical device company, experience in type testing support/trouble shooting will be preferred:

· Familiar with CFDA regulations/standards/technical guidance, and international regulations/standards， FDA, MDD, JPAL, KFDA regulation knowledge will be preferred

· Knowledge of ISO13485/ ISO14971/ISO14155 will be preferred

· Familiar with ophthalmic devices is preferred

· Good communication, facilitation and problem-solving skills

· Communicate effectively in English both verbally and in written form.

· Good computer skills, proficiency in office software

· Strong strategic problem-solving and project management skills.

· Strong cross-function collaboration capability and good teamwork sprit

· Proven record of successful completion of complex tasks.

· Willing to travel if necessary.

We are a boutique staff selection firm specialized in automotive, electrical/electronics, chemical, mechanical, engineering sectors. Our consultants and researchers all possess active track record in the staff selection business. We have continuously and successfully served multinational and sizeable local enterprises for their recruitment needs.
 
Our market positioning is clear that we are good at identifying middle level management and professional staff. We believe that a strong middle level is the key of business sustainability and development for all companies. Our years of experience in the staff selection industry give us thorough understanding on how to match the needs of employers and the advantages of candidates. We provide “no-frills” while focused services that is time and cost effective to both employers and ourselves.
 
We are in association with Recruit Holdings; a Hong Kong listed company that operates ***************, a leading recruitment portal in Shanghai. The shared resources enable us to access to a broader spectrum of candidates.