Regulatory Affairs Manager
Real Staffing is currently working with a Global Medical Device MNC and they are currently looking for a Regulatory Affairs Manager to join their office in Singapore. This position is an exciting opportunity that allows you to work closely with the regional and local Regulatory Affairs team in a fast pace environment.
Duration: 8-12 Months
Budget: Competitive Market Rate
- Plan and coordinate regulatory strategies appropriate to the intended use and target markets of medical devices designed, manufactured and distributed by the company.
- Represent Regulatory Affairs on selected cross-functional teams responsible for developing new products
- Develop and implement technical files and submissions to regulatory authorities such as FDA, TGA and Notified Body.
- Analyse the scientific content of submissions and advise stakeholders of their progress
- Manage design changes made to products to ensure continued compliance to global regulations. Produce non-significant change determinations as required.
- Ensure regulatory strategies for new product e.g. testing, standards, predicates, indications, etc. are implemented.
- Approve labelling and relevant marketing correspondence for selected products.
- Maintain an up-to-date knowledge on all regulatory compliance (both pre and post market) of existing company products in selected region(s).
- Bachelor's degree in pharmacy, life sciences or equivalent field
- At least 3 years of relevant work experience in Regulatory Affairs in Medical Devices industry
- Experience in managing cross functional projects
If you are interested in the above described position, appreciate if you can apply through the link provided or contact Angelica Desiongco at +65 68009560 for a confidential discussion.
Real, a trading division of SThree Pte Limited (Registration Number: 2007.20126E | SThree Pte Limited Licence Number 16S8216 | Real Licence Number 53132073A)
Award winner of:
International Recruitment Company of the Year by Recruitment International 2016
Life Sciences and Healthcare Recruitment Company of the Year by Recruitment International 2016
Best Overseas Operation by Global Recruiters 2017
Highly Commended for Best Large Recruitment Business 2017