Senior Ra Specialist

6 days ago

Singapore INTEGRITY PARTNERS PTE. LTD. Full time

I am currently representing a **medical device company **headquartered in **US **with a specialistation of **high risk medical devices **in **Orthopaedics **.

They are currently seeking a **Senior RA Specialist, APAC **to join their brilliant and ambitious team, to propel their regulatory activities in the region.

This successful incumbent will be focusing on planning and driving initiatives focused on operational excellence, playing a key role in aligning processes, facilitating rapid tactical execution of regulatory tasks and ensuring appropriate cross-functional transparency and accountability throughout the regulatory process.

**Main responsibilities**:

- Anticipate regulatory and related obstacles, staying ahead of emerging issues through development of regular reviews
- Support change management in APAC
- Perform activities relating to regulatory intelligence
- Act as the Global Regulatory Information Management System (RIMS) adminsitrator and regional support within the APAC, driving initiatives and facilitating the central i action of common documents to support global registration activities and processes.
- Support continuous improvement and process alignment of regulatory operations processes, systems and documentations within APAC
- Cross-functional collaborations with internal and external partners to identify technical solutions to translate RA processes into efficient workflows
- Develop regional technical capacity and capability, supporting product and technical file reviews

**Requirements**:

- Bachelor's Degree in a relevant field (e.g. Biomedical Engineering)
- At least 5 years' experience in medical devices regulatory affairs
- Fluent in regulatory processes and submissions
- Excellent knowledge of regulatory requirements in the US and/or EU is a plus
- Strong multi-tasking/project management skills, detailed-oriented and meticulous
- Keen eye for identifying gaps, proposing and establishing appropriate solutions for continuous improvement
- Great communicator and able to work both cross-functionally and independently

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

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