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- Regulatory affairs role with a Globally recognised Organisation
- Opportunity to develop and implement APAC regulatory strategies
About Our Client
Our client is a global leader in manufacturing of medical devices and deliver solutions to accelerate and improve diagnostic outcomes to the healthcare industries using cutting edge technologies. As the company is expanding, they are looking for an experienced regional regulatory affairs specialist to drive the development of the company's product quality and regulatory affairs strategy in the Asia Pacific region.
Job Description
- Manage the overall APAC Regulatory Affairs strategy and executive across APAC region
- Ensure the smooth and effective processing of the local and regional regulatory requirements in accordance with the company's regulatory strategies and plans
- Execute all regulatory activities including submission of new products or renewals until post-approval monitoring
- Compilation, review, coordination, submission, monitoring, follow up of regulatory submissions to ensure expedited processing in accordance with company time lines and targets
- Maintain close communication with regulatory authorities and other relevant local regulatory bodies and be up to date with all local regulatory updates and changes and cascade this to the team
- Represent the company as the primary communication point with the local regulatory authorities, industry groups and relevant stakeholders
- Develop, implement and maintain the required regulatory standards, standard operating procedures and resource documents
- Anticipate regulatory obstacles and emerging issues throughout the product life cycle
The Successful Applicant
- Bachelor's Degree in medical sciences or related discipline
- Regulatory Affairs working experience in medical device or pharmaceutical industry in Asia Pacific region
- Demonstrated ability to consistently achieve regulatory and quality requirements and meticulous
- Excellent knowledge and experience in the regulatory process for medical devices
- Strong engagement with country regulatory authorities and industry counterpart
- An effective problem solver and with the ability to make critical decisions
What's on Offer
The successful candidate will enjoy being part of a globally recognised MNC with an established presence in the market, that also provides career progression opportunities for its employees with attractive remuneration package and additional perks.
Contact
Vanessa Chan
Quote job ref
JN-102021-3607367
Phone number
+65 6643 9742
Job summary
- Function
- Healthcare
- Specialisation
- Healthcare
- What is your area of specialisation?
- Healthcare / Pharmaceutical
- Location
- Singapore
- Contract Type
- Permanent
- Consultant name
- Vanessa Chan
- Consultant contact
- +65 6643 9742
- Job Reference
- JN-102021-3607367
