Regulatory Affairs Specialist

20 hours ago

Singapore INTEGRITY PARTNERS PTE. LTD. Full time

**THE OPPORTUNITY**:
An esteemed **Medical Devices Company **is currently seeking a highly capable **Regulatory Affairs Specialist **to join their team. The successful incumbent will be tasked with the development and implementation of efficient regulatory strategies and processes, ensuring timely product registration, life cycle management, and post-market activities.

**RESPONSIBILITIES**:

- Offer business units solutions for regulatory pre-market activity issues and foster partnerships for effective implementation and resolution.
- Identify potential market opportunities by influencing and prioritizing product registration while reducing regulatory approval risks.
- Ensure effective communication and coordination between global, HQ RA, and manufacturing sites' RA for successful implementation of strategic plans.
- Lead and drive RA/QA activities to ensure timely registration of products or life cycle management, and mitigate post-marketing surveillance risks.
- Monitor relevant countries' regulatory changes to stay up-to-date on regulatory requirements.
- Develop regulatory and labeling plans for consistency and guidance during market introduction projects.
- Provide training and knowledge sharing sessions to Company's associates and distributors to ensure compliance with local regulations.
- Monitor distributor's regulatory competencies and provide effective solutions for quality RA work.
- Maintain compliance with local requirements while driving business growth.
- Foster a culture of regulatory excellence throughout the Company.

**EDUCATION AND EXPERIENCE NECESSARY**:

- A science degree related to the pharmaceutical, life sciences, or biomedical engineering fields is required.
- 1 to 3 years of experience in regulatory affairs, specifically in handling product registration and license maintenance for medical devices.
- Comprehensive understanding of regulatory practices, particularly in the APAC/ASEAN region.

Principal Consultant: Cheong Yee Yin | Registration Number: R22108633 | EA License Number: 17C8502

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