Job Description

How Will You Make an Impact?

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.

Position Summary: The Regulatory Affairs & Quality Manager South East Asia (SEA) is part of the APAC Regional Regulatory Affairs team, supporting the Specialty Diagnostics Group within Thermo Fisher Scientific. The position contributes to the growth in the region, driving the right strategic decisions for effective regulatory pathway to optimize and accelerate the time to market in South East Asia. The SEA Regulatory Affairs & Quality Manager is responsible to lead and support all aspects of regulatory requirements related to the Medical Device and In-Vitro Diagnostic, including RUO, LUO, LDT. What will you do: The incumbent will assess current / emerging regulations, guidance documents and corporate / industry standards for impact on the business area, collaborate effectively with the Commercial Leader from South East Asia Taiwan, on the expansion of the product portfolio and regulatory plan for Specialty Diagnostics Group and also work with the Divisional Leaders/ Local Country team and Distributor to ensure the optimal regulatory strategy meet the required legislation in the specific countries for the local market access registration. The role will call for a strong strategic orientation, an understanding how the Regulatory Affairs function drives commercial outcomes and ensures compliance with operating codes and ethical principles, and great people management skills. The incumbent will develop and maintain excellent talents and knowledges of procedures and environment related to Regulatory Affairs, and establish and maintain a network with the relevant policy makers and regulatory agencies. Key Responsibilities:

• Define, implement and execute effective regulatory and quality processes of Thermo Fisher Scientific SDG in compliance with respective Authority requirements in SEA.
• Lead the SEA RAQA team, develop the talents and ensure adequate resource for the region to support the business needs and growth.
• Lead and drive the strategic registration application in collaboration with Commercial Leaders, Country Leaders and/ or Channel Partners (distributors) to support the business with the expansion of the product portfolio and new product introduction in alignment with the organization’s strategies.
• Partner and work pro-actively with the SEA stakeholders, e.g. Commercial Leaders, Divisional Country Leaders, Channel Partners Operations and Distributors to ensure the optimal regulatory strategy complying with the required legislation in the respective country.
• Support and continuously monitor the distributor’s performance on timely renewals, regulatory submission and compliance to ensure smooth business with no disruption and the marketed products comply with the latest in-vitro diagnostic and/ or medical device regulation and other legislation. Improve and maintain the distributor database as per latest stage.
• Collaborate with Global Divisional Headquarters or manufacturing sites on the prioritization registration projects and regulatory plan, propose the measurable inputs as to achieve the earliest possible approvals of go-to-market.
• Review of dossier files before submission and collaborating with Global Regulatory team to resolve technical and documentation gaps and recommending responses to the questions from health authorities.
• Maintain the internal tracking tools and improve the workflow processes to ensure its efficiency.
• Coordinate and provide assessment to market responses or needs and provide change management assessment. Ensure the regulatory change and compliance will not impact the product in the market.
• Serve as Subject Matter Expert of local regulatory landscape and intelligence to Global Divisional Headquarters communicating regulatory and compliance changes and advising the Global Regulatory teams on the impact and action required.
• Ensure that SDG SEA comply with the latest Medical Device and IVD regulations building advocacy and rapport with regulatory authorities.
• Be the voice of Thermo Fisher SEA and actively involved in regional and/ or local regulatory and quality association.
• Lead and drive Global Post Market Surveillance activities, e.g. field safety notification, recall and other post-market surveillance in compliance with the reporting requirements of the local Authority.
• Review labeling and promotional materials for the local regulatory compliance within SEA.
• Support global and local initiatives, product lifecycle project and the regulatory inspections.

• Bachelor’s degree in biomedical engineering or equivalent field.

• Over 8 years of relevant work experience in Regulatory Affairs and Quality in either in-vitro diagnostic and/ or medical device industries.,
• Working in quality system audit and compliance.
• Project Management experience demonstrating ability to successfully lead all regulatory projects.

• Knowledge of in vitro diagnostic and/ or medical device registration and submission process in ASEAN (South East Asia) countries, additional advantage EU IVDR.
• Internal Auditor certified and understanding of ISO 13485 is advantage.
• Strong leadership skills with ability to engage Key Business Stakeholders in a matrix environment.
• Organizational skills with ability to priorities time effectively and meet agreed deadlines.
• Demonstrate good ability to identify internal & external customer’s needs and challenges to recommend realistic solutions to meet the needs of the business.
• Working experience in handling the distributors and good industry contacts.
• A good team player, who can work with the team member’s across the different countries. Positive attitude and be proactive and pragmatic.
• A good command of verbal and written communication skills in English is essential (Mandarin is advantage) together with the ability to think clearly and marshal ideas. Spoken communication must be clear and confident and must show evidence of good listening skills.
• Travel requirement approximately 15 - 20 %.