Position Summary:

• As an internal reviewer, check the submission documents according to regulation and best practice, give reasonable comments.
• Focus on regulation environment changes, improve review standard and transfer to stakeholders accordingly.
• Create and update related SOP/WI and share best practice among BUs.
• Mange product change notification process and organize discussion with stakeholders accordingly.

Principal Accountabilities:

• Develop the submission check plan according to priority and implement plan.
• Communicate regulatory governmental policy changes to BU RA in a timely manner and provide plans for meeting and complying with new requirements.
• Familiar with registration process and put into SOP/WI.
• Participation in applicable industry working groups and standards committees and communicates potential changes to the Global Business Units
• Manage multiple, sometimes conflicting priorities
• Work with government authority for getting the policy explanation promptly and correctly
• Provide supports to junior member in the team
• Training for the new and change regulation if necessary.

Qualifications:

• The candidate should have a minimum 3 years Regulatory Affairs experience in Medical Device Company in China or 3 years related authority’s experience in Medical device Evaluation function.
• The candidate should have a Bachelor’s Degree in related life science or advanced technical degree or equivalent.
• Workable English oral and write skill.

Job Competencies:

• Collaboration and Influencing:
• Candidate has to prove his/her ability to use formal and informal structure, dynamics and culture of an organization to get things done.
• He/She is self-confident in defending his/her position, while highly capable of aligning objectives with that of the overall organization.
• He/She has shown his/her ability to build relationships inside and outside the organization.
• Strategic Orientation: Candidate is able to analyze the evolving priorities of the business and integrate these insights into the sound strategy for his/her own area.
• Results Orientation: He/She has shown he/she has consistently delivered results and introduces best practices.

上班地址：北京