Job Title:         Snr. Regulatory Affairs Specialist SEA, Specialty Diagnostics Group (SDG)
 
Reports to:      Snr. Manager, Regulatory Affairs, SDG 
 
Location:         Singapore or Malaysia, depending on candidate's location 

 
 
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $24 billion and approximately 70,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity.  Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support. 
 
All of our employees share a common set of values - Integrity, Intensity, Innovation and Involvement. Our ability to grow year after year is driven by our ability to attract, develop and retain world-class people who will thrive in our environment and share in our desire to improve mankind by enabling our customers to make the world healthier, cleaner and safer.

If you share in our values and if you're looking for an employer who is strongly committed to developing talent and rewarding achievement, come grow with us at Thermo Fisher Scientific.
 
 
Position Summary:
 
The SDG SEA Regulatory Affairs is part of the SDG Regional Regulatory Affairs APAC team as Enabler and Strategic Business Partner, who contributes to the region's growth, driving right strategic decisions for effective regulatory pathway to optimize time to market.

The Senior Regulatory Affairs Specialist will be working proactively with the Commercial and/or Business Leaders from SEA, on the expansion of product portfolio and regulatory plan for SDG and work with Divisional Leaders and local country teams and/or distributors to ensure that optimal regulatory strategy meet the required legislation in specific countries to be registered for market access in an efficient and effective manner.
 
 
Key Responsibilities: 

• Work proactively with SDG SEA commercial and sales team to support the organization’s strategies.
• Build regulatory strategy and plan pre-market registration in SEA, communicate with local country team and/ or distributor to complete registrations for existing products and new expansion of product portfolio.
• Be the voice of SEA and work proactively with Divisional Headquarters or manufacturing sites on regulatory strategy and proposed measurable inputs for earliest possible approvals of go-to-market. Provide regulatory guidance to Divisional HQ on pre-market requirements.
• Ensure SDG SEA comply with required Medical Device and IVD regulations and its implementation in the region and build rapport with regulatory authorities.
• Reviewing submission files with local country team and/ or distributor and engaging the global Regulatory team in resolving technical and documentation gaps for local registration process.
• Recommend responses to questions from health authorities.
• Monitor regulatory submission, plan vs. actual to enable smooth business with no disruption and communicate with stakeholders on progress.
• Maintain the internal tracking tool, develop workflow processes and improve efficiency as necessary.
• Support license renewals on time by working in close collaboration with commercial/ sales team along with SEA distributors and/ or local country team.
• Coordinate and provide assessment to market responses/needs and provide change management assessment.
• Coordinate field safety notification and other post-market surveillance with local country team and/or distributor as directed by legal manufacturer according to reporting requirements of local Authority.
• Keep abreast of regulatory change and trends to ensure compliance with local regulatory requirements and advise global Regulatory teams on impacts. Be part of regional association and/ or network with Regulatory team of SEA distributors on regulatory change.
• Review labeling and promotional materials for regulatory compliance.
• Support product lifecycle project, the GDPMD quality management system and regulatory inspections of microbiology division and regional initiatives.

• Bachelor’s degree in biomedical engineering or equivalent field.
• Minimum of 4 years of relevant work experience in Regulatory Affairs in in-vitro diagnostic and/or medical device industry.
• Knowledge of in vitro diagnostic and/ or medical device registration and submission process in ASEAN (South East Asia) countries, additional advantage if you have EU CE IVDD/ IVDR knowledge or experience.
• Successful track record in communicating with ASEAN Regulatory Agencies.
• Understanding of ISO 13485 and GDPMD is advantageous.                                                              

• The job holder should show ability to work/ partner with internal stakeholders in a matrix environment and have ability to articulate country regulatory requirements to multiple stakeholders; demonstrate ability to identify internal & external customer’s needs and issues to recommend the realistic solutions to meet needs of the business.
• Project Management experience demonstrating ability to successfully lead a regulatory project is a plus.   
• A good command of verbal and written communication skills in English is essential. Mandarin is advantageous.
• Ability to think clearly and marshal ideas. Spoken communication must be clear, confident and display evidence of good listening skills.
• A good team player who can work independently.
• Travel requirement approximately 20%.
• Positive attitude, proactive and pragmatic.
• Experience of working with distributors and direct team, having good industry contacts.

• Proficient in Microsoft Word, Excel and PowerPoint is compulsory.

• Adherence to our organizational values of Integrity, Intensity, Innovation and Involvement.

 
 
At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. Apply today http://jobs.thermofisher.com
 
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.