JOB POSITION SUMMARY
Responsible for TW Surgical Vision IOL,OVD, Phaco and refractive Machine regulation affairs
- New Product/QSD Registration and Re-registration Accountabilities：
- 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.
- Analyze impact on license and business for change to legacy products and work out regulation strategy.
- Ensures product licenses are maintained against license expiry and TFDA submission/review.
- Regulatory Base Accountabilities：
- Interprets new and existing regulation across a wide range of topics including product registration, establishment licensing, labelling, import clearance, etc.
- Communicates existing and pending regulation to key business stakeholders (domestic, regional and global) including Regulatory Affairs, Marketing, Sales and Supply Chain.
- Maintains regulatory records.
- Provides input to domestic and regional SOPs.
- Labelling, Advertising and Promotion Accountabilities：
- Reviews, copy clears and maintains product labelling and Instructions for use in compliance with country specific regulation.
- 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.
- Support communication during promo applications to gain on time approvals in alignment with business strategies and supervise the promo’s legality.
DUTIES & RESPONSIBILITIES
1. Approval of NPI
2. LCM maintenance
3. New QSD maintenance
4. QSD maintenance
1. Product Recall & Stop shipment reporting to HA
2. ADR reporting to HA
3. Coordinate GDP submission/ approval.
1. Promotional material review
2. Regulatory intelligence and assessment
3. Collaboration with relevant associations for policy shaping activities
4. tendering material support
EXPERIENCE & EDUCATION
Bachelor’s Degree preferably in a scientific, technical, or engineering discipline or equivalent required; MD is preferred
- Masterful communication, negotiation, and interpersonal skills.
- Sense of teamwork
- Minimum 8-year experience in TW medical device industry with hands on experience obtaining regulatory approvals for medical devices
- Experience in the field of optometry and contact lens is a plus
Knowledge, Skills and Abilities:
- Skilled in establishing collaboration with internal and external partners, successfully influence functional business partners and able to work in a matrix environment.
- Strategic thinking with hands on knowledge and skill