北京招聘

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.

About Medtronic
Together Medtronic and Covidien are working to improve how healthcare addresses the needs of more people, in more ways and in more places around the world. As one company, we can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. This is the ideal opportunity to join us, and be part of our commitment to the health of others.

We know the combined resources of Medtronic and Covidien will be transformative, creating new methodologies and new opportunities. Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.

Medtronic is a $27.8b company with more than 85K employees in more than 160 countries.