2 дня назад
Senior Regulatory Affairs Specialist (MedTech), Philippines
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Regulatory Affairs Specialist (MedTech), Philippines (medical devices/regulatory affairs): Preparing regulatory submissions and supporting compliance for medical device products in the Philippine market with an accent on product registrations, labeling reviews, health authority coordination, and regulatory strategy. Focus on managing approval databases, supporting product launches and special access schemes, monitoring regulatory changes, and maintaining uninterrupted product supply.
Location: Taguig, National Capital Region (Manila), Philippines
Company
Johnson & Johnson MedTech develops healthcare and medical device solutions as part of Johnson & Johnson.
What you will do
- Prepare submissions to the Philippine health authority for new medical devices and variations to existing products.
- Provide input into global regulatory strategy and identify local requirements for registrations, indications, and line extensions.
- Review labeling and promotional materials and maintain databases of regulatory approvals.
- Coordinate documentation with global regulatory colleagues and build working relationships with the local health authority.
- Support product launches, Special Access Scheme and Special Access Importation releases, audits, and regulatory process improvements.
- Coordinate with marketing, stakeholders, and distribution centers to support regulatory pathways and uninterrupted product supply.
Requirements
- Bachelor’s degree in pharmacy and an active pharmacist license registered in the Philippines.
- Familiarity with medical device regulatory systems and product registration requirements.
- Practical experience with the market health authority, preferably a medical device health authority.
- Strong attention to detail, analytical and comprehension skills, and a methodical approach to documentation and data handling.
- English proficiency is required. Excellent verbal and written communication skills are expected.
- Ability to work effectively in a matrixed, fast-paced environment and adapt to a changing regulatory environment.
Culture & Benefits
- Inclusive work environment that respects diversity, dignity, and individual contributions.
- Collaborative regulatory affairs team environment with knowledge sharing and best-practice discussions.
- Interaction with industry associations and health authorities as required.
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