北京招聘

• New Product Registration and Re-registration Accountabilities：

1. Using input from key stakeholders and global platform teams creates new product registration strategies and plans and ensures execution in support of local/regional business plans.

2. Analyze impact on license and business for change to legacy products and work out regulation strategy.

3. Ensures product licenses are maintained against license expiry including type testing and CFDA submission/review.

• Regulatory Base Accountabilities：

1. Interprets new and existing regulation across a wide range of topics including product registration, establishment licensing, labelling, import clearance, etc.

2. Communicates existing and pending regulation to key business stakeholders (domestic, regional and global) including Regulatory Affairs, Marketing, Sales, Supply Chain and TVCI.

3. Maintains JJVCI’s regulatory records.

4. Provides input to domestic and regional SOPs.

• Labelling, Advertising and Promotion Accountabilities：

1. Reviews, copy clears and maintains JJVCI product labelling including local carton and Instructions for use in compliance with country specific regulation.

2. In partnership with Global Regulatory Affairs define, implement and establish regional copy clearance procedures that capture product lifecycle obligations in alignment with business label strategies.

3. Support communication during promo applications to gain on time approvals in alignment with business strategies and supervise the promo’s legality.

• Clinical Trial Support Accountabilities：

Oversees local type testing activities in support of clinical trial activities.

Qualification

? Education:

Bachelor’s Degree preferably in a scientific, technical, or engineering discipline or equivalent required; MD is preferred

? Experience:

1. Minimum 8-year experience in medical device industry with hands on experience obtaining regulatory approvals for medical devices

2. Experience in the field of optometry and contact lens is a plus

? Knowledge, Skills and Abilities:

1. Skilled in establishing collaboration with internal and external partners, successfully influence functional business partners and able to work in a matrix environment.

2. Strategic thinking with hands on knowledge and skill

3. Masterful communication, negotiation and interpersonal skills.

4. Sense of team work

强生视力健商贸（上海）有限公司诚聘