Our client is one of the fast-growing medical device companies and they have a new opportunity for Regulatory Affairs/Quality Assurance Manager to be part of the team in Singapore regional HQ. The incumbent will be responsible for developing and implementing the product registration strategies to create sales opportunities for new products and ensure the continuity of sales for existing products in the regions, with total compliance to the local, regional, and international regulatory environment.
- Create and implement the regulatory registration strategies for new products in the designated regions
- Manage and oversee the entire process of product registration
- Be the point of contact and work closely with the local regulatory authority and regional partners to answer any queries
- Provide regulatory guidance and advice if necessary
- Manage the life cycle of existing products and renew the licenses if required
- Ensure product compliance by assessing the local and regional product regulations, keeping track of the changes, and maintaining records of product registration statuses
- Maintain all records of SOPs, legislation and regulations to facilitate the product registration processes
- At least Bachelor's degree in Biological Science or related discipline.
- At least 5 years of experience in Regulatory Affairs, preferably in medical technology industry.
- Must have experience with ASEAN regulatory submission
- Excellent project management skills
- Have experience with operating using international guidelines
Interested applicants please click APPLY NOW or submit your updated resume in Word format quoting reference number JO-1811-406834
We regret to inform that only shortlisted candidates will be notified.
Consultant Name: Haw Yu Xuan
EA Personnel Registration Number: R1769909