37 Product Registration jobs in Singapore

We are seeking a dynamic and experienced Product Marketing Expert to oversee the entire product lifecycle for assigned regions.

This role requires strong leadership skills to drive successful product launches, collaborate with cross-functional teams, and analyze market trends to inform strategic decisions.

The ideal candidate will have a proven track record of developing and executing product marketing strategies that drive business growth and customer engagement.

• Develop and execute comprehensive product marketing plans to drive business growth and customer engagement.
• Collaborate with cross-functional teams, including sales, product, and design, to align on product launch strategies and tactics.
• Analyze market trends and competitor activity to inform strategic decisions and stay ahead of the competition.
• Leverage data and analytics to measure campaign effectiveness and optimize future product marketing efforts.

• Proven experience in product marketing, preferably in a technology or software industry.
• Strong leadership skills, with the ability to motivate and guide cross-functional teams.
• Excellent communication and project management skills, with the ability to work effectively in fast-paced environments.
• Creative problem-solving skills, with the ability to think strategically and outside the box.

This role offers a competitive salary, comprehensive benefits package, and opportunities for professional growth and development. As a valued member of our team, you will have access to cutting-edge tools, technologies, and training programs to help you succeed in your role.

You will also have the opportunity to work with a talented and dedicated team of professionals who share your passion for innovation and excellence.

We are committed to fostering a positive and inclusive work environment that values diversity, equity, and inclusion. We encourage applications from qualified candidates who share our commitment to these values.

Position Summary:

The Senior Engineer – Product Lifecycle is responsible for leading the development, optimization, and sustaining of manufacturing processes for high-volume production of life science consumables, with an emphasis on disposable plastic components. This role manages technical interfaces with Contract Manufacturers, oversees process validation and control, and ensures compliance with quality and performance standards. The position requires coordination with cross-functional teams including R&D, Quality, and Manufacturing to support new product introductions, implement process improvements, and resolve production issues. The engineer is also accountable for supplier performance monitoring, tooling qualification, and the transfer and scale-up of manufacturing processes to external partners.

Position Responsibilities:

• Serve as the process owner for manufacturing processes at Contract Manufacturers for plastic cartridges, including but not limited to precision injection molding, laser welding, ultrasonic welding, mechanical assembly, and fluidic functional test.
• Define product specifications, process control indicator, test strategy, and supplier's performance KPI for high volume disposable products.
• Accountable to resolve manufacturing issues related to yield, quality and throughput, in timely manner.
• Actively seek out for continuous improvement opportunities in yield, quality and cost.
• Collaborate with R&D, Manufacturing and Quality to develop molding and assembly processes for new products and improve processes of existing products.
• Lead technical and production teams to support pilot run and define scale-up manufacturing strategy at contract manufacturers.
• Candidate must thrive in a dynamic environment and place great emphasis on meeting milestones and breaking down barriers to achieve results.

Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

Position Requirements:

• Strong background in precision plastics molding and assembly processes required.
• Proven track record in managing Contract Manufacturing (CM) to resolve manufacturing & customer's issues.
• Proficient in CAPA and structured problem-solving methodologies.
• Skilled in application of statistical tools including SPC, DOE and process capability analysis (PPK, CPK).
• Experience with product development lifecycle and project management required.
• Familiarity with the design and qualification of manufacturing jigs & fixture, equipment and automation solutions.
• Strong interdepartmental communication skills and documentation skills are required.
• Exposure to digital technology such as data analytics, RPA and AI applications.
• Willingness to travel for supplier engagement and technical support.

All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.

Preferred Experience/Education/Skills:

• Bachelor's degree in mechanical engineering, Bioengineering, Plastics Engineering, Materials Science, Chemical Engineering, or a related field.
• 5–9 years of relevant experience in biotech or medical device manufacturing.
• Proficiency in Solidworks or equivalent CAD tool.
• Experience in regulated environments (e.g. ISO 13485, GMP) is a plus.

Position Summary:

Responsible for supporting product transfer, instrument manufacturing, troubleshooting, failure analysis, quality improvement, process enhancement, cost reduction, engineering evaluation and system improvement.

Position Responsibilities:

• Support and drive activities to ensure successful product transfer into manufacturing.
• Drive troubleshooting, failure analysis, root cause analysis, issues closure and corrective action processes as required.
• Perform instrument setup, calibration and final system integration test.
• Establish and maintain databases of instrument failures and defects.
• Perform data trending analysis, construct and execute design of experiments to address yield and quality issues.
• Drive and implement process improvements and product sustaining activities to meet the production goals.
• Drive maintenance and improvement activities on test fixtures and equipment.
• Drive and implement cost reduction activities by perform engineering evaluation to qualify new or improved materials, processes and products.
• Apply various analysis techniques, such as FMEA and statistical analysis to optimize product quality and minimize cost, providing all calculations, performance data, and drawings required on new and existing products.
• Manage and coordinate Engineering Change Order implementation activities including scrap analysis, material disposition, update work instructions and test requirement changes.
• Documentation responsibilities include, but not limited to, generating detailed engineering drawings, Bill of Materials, test reports, assembly procedures and design validation plans.
• Work closely with contract manufacturing partners and key suppliers to ensure smooth transition of quality products from development into manufacturing.
• May require frequent travels to US.

All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.

Position Requirements:

• Bachelor's degree or Master in Mechanical or Electro-mechanical Engineering.
• 3+ years of engineering experience in mechanical or electro-mechanical based products for commercial and industrial markets.
• Good working knowledge and experience in mechanism design and electro-mechanical systems.
• Strong organizational skills, attention to detail and accuracy, and the ability to work independently in a team environment are essential.
• Good knowledge of GD&T, plastic & sheetmetal tooling, casting, mechanism, stress analysis, mechanics, machining and standard manufacturing processes.
• Candidate must be able to effectively interface well with the manufacturing and service organization, and has a proven track record of transferring products to manufacturing.
• Must possess good analytical and troubleshooting skills.
• Proficient in engineering tools such as, statistical analysis, design of experiments, product and process capability analysis.
• Proficient in Solidworks or 3D CAD tools.
• Experience with FDA regulated medical device product development preferred.
• Product development experience in the life sciences, biotech, biomedical or nanotechnology industries preferred.

We are seeking a highly skilled Clinical Development Specialist to lead the management of our product/program life cycle.

This includes being a team resource and expert through various stages, including research on customer needs, R&D, sales trials, product launch, post-market surveillance, inventory management, and field support.

Key responsibilities include:

• Contribute to the development of strategies to increase market adoption and penetration of our best solutions.
• Develop expertise on how our devices/programs are used by customers and maintain knowledge of main competition.
• Provide leadership and expertise for any product/program development or enhancement projects, including design input, design validation, hazard analysis, clinical data research and compilation, post-market surveillance, complaints, labels & Instructions for Use (IFU), and pricing.
• Forge relationships with thought leaders in their respective markets to enhance understanding of clinical needs.
• Contribute to strategic decision-making for product/program life cycle.
• Manage sales trials or education projects relating to product/program launches or improvements.
• Protect and build product brands, including participation and contribution to organized national and international meetings and congresses.
• Mentor team members and act as a recognized resource to local team.
• Assist in other cross-functional and interdepartmental projects that may require support.

This role requires close collaboration with various teams, including Clinical Development, Engineering, Market Implementation, Branding, Regulatory, Education, and Field Implementation.

Our ideal candidate will possess:

• Expertise in clinical development and product life cycle management.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Ability to work effectively in a team environment.
• Proficiency in Microsoft Office and/or similar software applications.

As a member of our team, you will enjoy:

• A competitive salary and benefits package.
• Opportunities for career growth and professional development.
• A dynamic and supportive work environment.
• Recognition and rewards for outstanding performance.

Principal Task: The successful candidate will first and foremost be responsible for regulatory affairs and product registrations for all SciMed products. The candidate will be the focal point of contact for advice on regulatory guidelines and activities. Besides regulatory affairs, the candidate will also support the Management Representative in ensuring an effective Quality Management System (QMS) and local implementation of PHC's compliance policies and ensure full adherence where necessary.

1. Regulatory Affairs

• Understand relevant regulatory regulations, policies & procedures behind the company's business activities and products
• Ensure product and company's compliance with regulations for maintenance of approvals
• Maintain ISO and GDPMDS records, and work closely with the ISO/GDPMDS team to provide timely updates on company's regulatory and licensing matters
• Preparation and submission of regulatory applications, including creating and maintaining templates and ensuring completion of submissions
• Advise management on regulatory processes, compliance and updates to policies
• Responsible for the maintenance of regulatory documentation databases
• Develop and maintain communication with regulatory agencies regarding submission strategies, compliancetest requirements, potential regulatory pathways, or clarification, and follow-up on submissions and reviews quality management systemo new product(s) launch in local and/or regional markets
• Main contact point for various regulatory-related internal inquiries regarding logistics, pre/post-marketing events in addressing customers' requirements.
• Support the country managers in medical device regulations or other regulations for regional countries
• Liaise with related departments in the PHC Group

2. Quality Management System

• Support the Management Representative in the company quality management system
• Maintain and update the document control system to ensure all quality-related documents are easily accessible, properly categorized, and up to date.
• Oversee the implementation and maintenance of Quality Management Systems (QMS) in accordance with ISO9001, GDPMDS and other relevant standards.
• Review and update ISO 9001 & GDPMDS documents when necessary and maintain records.
• Review and ensure all documents, including SOPs, work instructions, manuals, and forms, meet regulatory and company standards.
• Handle quality related matters such as non-conformances, customer complaints, change notification.
• Handle customer or supplier related enquiries, questionnaire and etc.
• Prepare for internal and external audits and ensure successful outcomes, tackle audit findings and recommendations in a timely manner
• Follow-up and verify corrective/preventive action (CAPA) effectiveness.
• Provide ISO 9001 and GDPMDS orientation to new employees

3. Compliance

• Coordinate, schedule and conduct required compliance orientation and training for employees
• Responsible to ensure compliance to regulations related to export controls and maintain records
• Provide support to employees on regulatory requirement and compliance procedures.
• Serve as a BizSafe member by overseeing and coordinating the preparation, management, and maintenance of all risk management and related documentation. Ensure all required documents are completed, up-to-date, and in compliance with BizSafe standards and regulations.

REQUIREMENTS

Candidates should bring with them

• A Degree in Life Sciences, Biomedical or any other related discipline.
• Minimum 2 years' experience in performing a similar job scope.
• Relevant experience in regulatory affairs will be advantageous
• Good knowledge and application of Microsoft 365.
• Able to work under a matrix reporting structure.
• Good organizational and time management skills.
• A strong database experience (Access, Excel) to set up functions, enter data or process information.
• Excellent interpersonal, presentation and verbal/written communications skills.
• Meticulous, able to work independently and timely in meeting deadlines.
• Integrity with a history of ethical decision-making is essential
• Sound knowledge of the regulatory requirements and legal framework for products and industry trends in the Asian Region.
• Knowledge in GDPMD, ISO9001, IVDR preferred.
• Familiarity with Health Science Authority's regulatory on medical devices, product registration, field safety correction and licensing requirements.

We are seeking an experienced professional to lead and drive transformational improvements in our product launch lifecycle.

This pivotal role will enhance cross-functional alignment, optimize workflows, and improve the efficiency and cost-effectiveness of our product launch process. The ideal candidate will have a proven track record of leading and implementing process improvements that result in significant business benefits.

• Evaluate existing processes to identify gaps, inefficiencies, and improvement opportunities.
• Design and implement scalable, standardized workflows aligned with industry best practices.
• Collaborate with cross-functional teams to drive process improvements.
• Develop robust planning tools, templates, and documentation to support process scalability.
• Lead training workshops and facilitate adoption of new tools and processes.
• Track and report KPIs to monitor process performance and continuous improvement progress.

• 8+ years of experience in process improvement, manufacturing operations, or supply chain management, ideally in high-tech or regulated sectors.
• Proven expertise in process improvement methodologies such as Lean, Six Sigma, or Kaizen.
• Proficiency in ERP/MRP and project management systems.
• Strong change agent with experience leading cross-functional process improvements.
• Preferred certifications: PMP, Lean Six Sigma (Green or Black Belt).
• Bonus: Experience in digital transformation or automation of planning systems.
• Familiarity with Agile or hybrid project management methodologies is a plus.