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Regulatory Affairs

[Vision] Assistant Regulatory Affairs Manager

  • Job Title [Vision] Assistant Regulatory Affairs Manager
  • Function Regulatory Affairs
  • Sub Function Regulatory Affairs
  • Location Taipei, Taiwan
  • Date Posted
  • Requisition Number 2206087793W
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Description

JOB POSITION SUMMARY

Responsible for TW Surgical Vision IOL,OVD, Phaco and refractive Machine regulation affairs

  • New Product/QSD 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 and TFDA 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 and Supply Chain.
  3. Maintains regulatory records.
  4. Provides input to domestic and regional SOPs.
  • Labelling, Advertising and Promotion Accountabilities:
  1. Reviews, copy clears and maintains product labelling 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.

DUTIES & RESPONSIBILITIES

Regulatory Affairs:

1. Approval of NPI

2. LCM maintenance

3. New QSD maintenance

4. QSD maintenance

Quality Assurance:

1. Product Recall & Stop shipment reporting to HA

2. ADR reporting to HA

3. Coordinate GDP submission/ approval.

Others

1.     Promotional material review

2.     Regulatory intelligence and assessment

3.     Collaboration with relevant associations for policy shaping activities

4.     tendering material support

EXPERIENCE & EDUCATION

  • Education:   

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

  1. Masterful communication, negotiation, and interpersonal skills.
  2. Sense of teamwork

Experience:  

  • 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

Qualifications

See above

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