Global RA/QA Specialist
ProClinical is seeking a Regulatory Specialist role for a world leading medical device company, to be based in Singapore on a permanent basis. The role will participate in the development of the product regulatory compliance policies and requirements and their implementation by considering worldwide regulatory environment, to define tools to support and ensure regulatory compliance world wide of the company's products and monitor a regulatory watch to support the core business and company innovations.
- Participate in the development of the group's product regulatory policies and requirements by proposing operational tools to spread them to the Group.
- Realize global regulatory intelligence and watch thanks to the support of local relays (local compliance managers).
- Bring expertise in product regulatory compliance in new product projects, industrial projects, trade...
- Write regulatory documents in the context of local product registration.
- Built training materials for corporate teams and regions (R&D, logistics, trade, local compliance managers…).
- Support regulatory audit plan training (products/process/ quality ...).
- Contribute to complex incident resolution involving various territorial entities.
- Bring regulatory expertise for R&D wearer test, incidents analysis.
Skills and Requirements:
- 5 to 10 years of experience in regulatory position in manufacturing industries within an international environment.
- The knowledge of ophthalmic industry and/or medical device industries will be an advantage.
- Good knowledge of Office software, Google environment and data analysis/reporting tool
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Mandy Fang on +65 3159 1467 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
R1215238 | EA13C6865