Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

How will you make an impact?

At Thermofisher Scientific, we provide outstanding and multifaceted environment for you to grow both personally and professionally, with phenomenal support from the company.

The Regulatory Affairs & Quality Manager is a member of APAC Regional Regulatory Affairs team, supporting the Specialty Diagnostics Group. You will provide the required expertise, strategic direction supporting the business growth, building the right decisions for effective regulatory pathway in optimizing and accelerating time to market in this region. Leading all aspects of regulatory requirements related to clinical In-Vitro Diagnostic and non clinical such as RUO, LUO and LDT, as well product for food and pharma customers.

• Lead SEA Q&RA team, develop the current talents and ensure sufficient resource to support the business growth. Implement effective regulatory and quality policy.
• Regulatory Partner to SEA collaborators - Commercial, Division Leaders, Channel Partners Operations and Distributors. Lead pre-market registrations to support business expansion and new product introduction in line with Group's and Division's strategies. Collaborate with distributors, coordinating their performance to ensure there is no disruption to the marketed products, improve the process where necessary.
• Collaborate with Global Divisions on prioritization of projects, regulatory plan, propose measurable inputs to achieve the earliest possible approvals for go-to-market.
• Coordinate and provide regulatory assessment to market responses and needs during product lifecycle management, ensure change will not impact the product in the market.
• Become an Expert in regulatory landscape and intelligence, communicate with clarity, evaluate the impact and provide the required actions to meet the latest Medical Device and IVD regulations.
• Building advocacy and rapport with Regulatory Authorities, actively engage and represent Thermo Fisher in regional and local trade association.
• Implement global post market surveillance, field safety notifications, recalls according to local reporting requirements.
• Evaluate the labeling and promotional materials meeting local regulatory requirements.
• Singapore Management Representative of Thermo Fisher Microbiology ensuring Goods Distribution Practice (GDPMDS) requirements and certification.