Regional Regulatory Affairs Manager (Medical Device Industry)
Medical Devices Industry
About Our Client
A medical device company which is the headquartered in Singapore. They have R&D facilities in Japan and Singapore; a manufacturing plant in Singapore; sales and marketing offices in Europe, Japan, Singapore, and U.S.
As a Regional Regulatory Affairs Manager (Medical Device Industry) your responsibilities will include but not limited to:
- Oversees APAC registration status update and regulatory control for product release throughout supply chain system.
- Participation in Singapore, APAC and/or global level in projects where regulatory input is required.
- Providing input to the APAC Submission Plan with regard to regulatory strategies to obtain approval for new products or planned changes
- Ensures that submissions are executed on-time and in a cost-effective manner.
- Licenses for approved products are maintained and renewed on-time.Adequate and effective relationship management with Third Party License Holders, Legal Agents, Regulatory Agencies, Consultants, and internal stakeholders in order to meet the regulatory goals and timelines.
- Accountable for compliance of the submitted registration files with internal requirements and external regulations.
- For post-market changes, ensure impact assessment is identified in the affected country and change notifications are submitted accordingly with minimum impact on product supply or internal processes.
- Monitors changes in local standards, regulations, guidance documents etc.
- Provides regulatory expertise within the APAC RA team (e.g. RA specialists) and to other stakeholders on complex regulatory issues.
- Support departmental internal audit.
- Oversees the adverse event reporting review for complaints, AE and FSCA reporting to authority.
The Successful Applicant
The ideal Regional Regulatory Affairs Manager (Medical Device Industry) that we are looking for should have:
- BSc in a related filed - science, engineering, quality, clinical studies
- 5 years submission experience in Regulatory Affairs in Medical Device/Pharmaceutical industry in Southeast Asia, India, Taiwan and Korea.
- Hands-on preparation of submission documents, and handling regulatory submissions in Distributor and Direct markets across APAC.
- Well-developed project management skills
- An analytical and strategic approach to planning and problem solving
- Ability to effectively communicate with the suppliers, both internal and external
- Competence to manage timelines
What's on Offer
Continuous development and career advancement opportunities within the organisation.