7 дней назад
MedTech_Sr. RA Specialist_Vision (MedTech)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
MedTech Senior Regulatory Affairs Specialist (Vision): Leading product registrations, renewals, post-approval changes, and regulatory compliance for J&J Vision products in Hong Kong and Macao with an accent on dossier preparation, lifecycle management, and local regulatory requirements. Focus on reviewing labeling and promotional materials, responding to health authorities, supporting tendering, and coordinating cross-functional product launches.
Location: Hong Kong, Hong Kong; responsibility covers Hong Kong and Macao.
Company
Johnson & Johnson MedTech develops innovative, less invasive, and personalized healthcare and vision solutions.
What you will do
- Lead regulatory dossier preparation for product registrations, renewals, and post-approval changes in Hong Kong and Macao.
- Prepare submissions, manage authority questions and official correspondence, and maintain regulatory databases, trackers, and archives.
- Monitor regulatory changes and provide impact assessments, interpretations, and compliance recommendations.
- Review and approve artwork, labeling, packaging, instructions for use, promotional materials, and educational materials.
- Support tendering activities and serve as the primary regulatory contact for health authorities, customers, and internal teams.
- Collaborate with commercial, quality, supply chain, product development, and regional and global regulatory affairs teams.
Requirements
- Senior-level expertise in regulatory affairs, product licensing, regulatory compliance, and medicines and device development and regulation.
- Experience managing product registrations, renewals, post-approval changes, and lifecycle activities.
- Ability to interpret regulatory requirements and provide practical compliance guidance.
- Strong accountability, collaboration, cross-functional working, and stakeholder management skills.
- Ability to support regulatory submissions, promotional review, tendering, and product launches for Hong Kong and Macao.
Culture & Benefits
- Inclusive work environment focused on respecting individual dignity, diversity, and merit.
- Work within a global MedTech organization focused on healthcare innovation and patient outcomes.
- Opportunity to contribute to SOP updates, process optimization, and regulatory best-practice sharing.
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