Regional Regulatory Affairs Specialist
Consultant Archita Tekriwal (R1659919)
Date posted 25 January 2019 2019-01-252019-03-19 medical-and-nursing Singapore SG SGD 70000 90000 90000 YEAR Robert Walters https://www.robertwalters.com.sg
An exciting Regional Regulatory Affairs job has just opened up at a Globally leading and reputable medical devices MNC. This role is responsible for managing Regulatory Affairs for new and existing products as well as supporting New Product Development for the entire ASEAN region.
About the Regional Regulatory Affairs role:
The role is responsible in ensuring that all new and existing products are registered with the relevant Government Authorities, and support the new Product Development and Innovation Centre.
- Handles product registration with HAS
- Compiles registration dossiers for new product registrations according to regulatory plan and local legislation for Singapore and ASEAN Developing Markets
- Sources and provides documentation for registration of Singapore products in international markets, collaborating with RA colleagues in international markets
- Timely submission, license renewals, and regulatory compliance
- Provides regulatory oversight and guidance for product development projects and develop global regulatory strategy for product development projects
- Provide the Marketing teams with regulatory input in order to obtain timely regulatory approvals for the products as part of the product registration and work closely with the supply chain and manufacturing to help manage stock levels and implement innovative solutions
- Develop & maintain regulatory intelligence of ASEAN, EU, US and other international markets regulations.
- Monitor changes in the regulatory environment in order to formulate appropriate company response to facilitate new and support ongoing registration activities
- Liaise with HSA and Notified Bodies to maintain regulatory compliance of legal manufacturer in Europe and Singapore
- Support GMP compliance and inspections for any other international regulatory body that requires it
To succeed in the Regional Regulatory Affairs job, you must have at least three years’ regional regulatory exposure in the medical device industry.
- Familiar with European Medical Device Directive, US 510K and desirable with practical experience
- Excellent verbal and written communication skills
- Demonstrated ability to be innovative
- Demonstrated resilience working under pressure
- Keen to learn
This company supports health care professionals in more than 100 countries in their daily efforts to improve the lives of their patients by taking a pioneering approach to the design their advanced medical products and services, by securing wider access to diverse technologies for more customers globally.
If you are a regulatory affairs professional seeking to advance your career in an ambitious and growing company, this is the right next step for you.
Apply today or call me for further details.
Robert Walters (Singapore) Pte Ltd
ROC No.: 199706961E | EA Licence No.: 03C5451
EA Registration No.: R1659919 Archita Tekriwal