Regulatory Affairs Senior Specialist

1 week ago

Singapore CooperSurgical Full time

CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families. We currently offer over 600 clinically relevant medical devices to women's healthcare providers, including testing and treatment options.
- Bachelor's degree / Masters in relevant field Engineer, Bio Science, Technical or alike
- 3-5 years of experience from a similar role, - preferable medical device
- 3 - 4 years in an international company
- Regional and local experience with regulatory affairs
- Good project management
- skills
- Structured and systematic approach
- Strong communication and problem-solving skills
- Proficient level in MS office
- Fluent English and Thai (spoken and written) is mandatory

At CooperSurgical (CSI) we are currently looking to recruit a **Senior Regulatory Affairs Specialist for our Thailand and Emerging Asia markets **. You will be responsible for all Regulatory affairs activities

primarily for Thailand with the oversight for other Emerging Asia countries such as Vietnam and Cambodia. Your primary focus will be on product registration and license renewal activities of our fertility solution and medical device segment in the region.

You will report to the RA manager placed in Singapore and the role is hybrid.

**Location**:Thailand, - preferable Bangkok

Position

In the role as **Sr.RA specialist **for emerging Asia markets, you will liaise closely with our current consultant and distributors in all matters related to regulatory affairs. You will lead and support the product registrations and renewal of licenses for our fertility solution and medical devices portfolios and liaise with the local authorities when needed, while keeping abreast of updates, guidelines and new regulations. You will also support and assist in the internal and external audits and support the RA team in Asia.

You have strong experience with the regulatory requirements for Class IIa and IIb medical devices in Asia and have good communication skills.

You thrive in a dynamic environment. By using your collaborative capabilities, planning and prioritization skills, you can meet deadlines and follow-up with stakeholders. You will work closely together with teammates and stakeholders in the organization. The position as Senior RA Specialist in Asia is vital for the success and growth of the CooperSurgical company.

**Your key responsibilities
- Lead product registration and license renewal in Emerging Asia especially Thailand
- Drive collaboration with distributors, local authorities, CSI Consultant and internal cross functional team.
- Ensure KPI and timelines are meet
- RA advisor and representative for internal and external audits
- Foster team spirit and global collaboration
- Keep abreast on local regulation updates and/or changes

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