Regional RA Manager - Medical Devices

Regional Regulatory Affairs Manager

In this position, you will:
* 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 to ensure they are accurate and soundly presented.
* Monitor the status 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.
* Educate, inform and influence design and manufacturing staff to obtain satisfactory and efficient regulatory outcomes
* Ensure regulatory strategies for new product: e.g. testing, standards, predicates, indications, etc. are implemented.
* Approve labelling and relevant marketing correspondence for selected products.
* Monitor external standards: e.g. design standards (ISO, IEC, etc), European harmonised standards, FDA policies and guidances, national and international regulatory requirements, industry journals, etc.
* Monitor internal standards and act appropriately: e.g. new products, changes to existing products.
* Maintain an up-to-date knowledge on all regulatory matters and advise senior management of potentially significant changes.
* Manage the continuance of regulatory compliance (both pre and post market) of existing products in selected region(s).
* Ensure clinical trials are conducted in accordance with the best opportunity to achieve regulatory approval
* Provide post market regulatory support (e.g. Medical Device Reporting) and guidance as required.
* Manage special projects as required
* The ideal candidate should have the following qualifications:
* Engineering or Life Science Degree or equivalent
* 5-7 years related experience with a medical manufacturer or equivalent combination of education and experience.
* Managing existing and future regulations and standards so that they are implemented into products in an effective and timely manner.
* Working concurrently on several cross functional projects to meet business priorities will require effective time management and a broad base of personal and interpersonal effectiveness.
* Proven project leadership skills
* Excellent written and verbal communication skills
* Ability to influence and negotiate at various levels within the project team and with external partners while maintaining positive working relationships
*Demonstrated ability to critically think and analyse scientific information while paying close attention to detail

If you are interested in discussing further on the opportunity in a confidential manner, or other Regulatory Affairs opportunities in the medical device and pharmaceutical industry, please contact Jennifer Ha at j.ha(@)realstaffing.com or contact +65 6871 4700.

Real, a trading division of SThree Pte Limited (Registration Number: 2007.20126E | SThree Pte Limited Licence Number 16S8216 | Real Licence Number 53132073A)

Monthly Salary: SGD 11000

Application Email: JIHA.23371.3273@sthreesg.aplitrak.com