Senior Specialist, RA & QA (3-6 months contract)

Keywords: Regulatory Affairs, Quality Assurance, Medical Devices, Product Registration, Compliance, GDPMDS, ISO Standards, Post Market Surveillance, SOP Review, Cross-country Collaboration

A leading organisation in the medical device sector is seeking a Senior Specialist in Regulatory Affairs and Quality Assurance (Contract) to join their Singapore-based team. This role offers you the opportunity to play a pivotal part in ensuring regulatory compliance and maintaining high standards of quality across Southeast Asia. This position provides an excellent platform for professional growth within a supportive environment that values your expertise and commitment to excellence. You will benefit from exposure to international projects, and the chance to collaborate with knowledgeable colleagues who are passionate about making a positive impact on healthcare outcomes. If you are looking for a role where your attention to detail, collaborative spirit, and passion for quality can truly shine, this is the perfect next step in your career.

• Be part of a collaborative team that supports your professional development through training opportunities and cross-country project involvement.
• Experience a workplace culture that values flexibility, inclusivity, and knowledge-sharing, empowering you to grow both personally and professionally.

What youll do:

As a Senior Specialist in Regulatory Affairs and Quality Assurance, you will be instrumental in safeguarding compliance across Southeast Asias dynamic medical device landscape. Your day-to-day responsibilities will involve managing complex product registrations, coordinating with multiple stakeholders to ensure timely submissions, and maintaining meticulous records that support ongoing compliance efforts. You will play a key role in monitoring post-market activities by reviewing feedback systems, addressing complaints efficiently, and driving corrective actions when necessary. Your expertise will also be called upon during audits where youll help uphold rigorous quality management standards. By analysing customer feedback and generating insightful reports, youll contribute directly to process improvements that enhance patient safety. Additionally, your collaborative approach will see you working alongside teams across borders on various projects while adapting quickly to evolving priorities. This multifaceted position offers you the chance to make a tangible difference every day while developing valuable skills within an inclusive environment.

• Coordinate and submit timely product registrations, license renewals, and amendments for new and existing products across Southeast Asia, ensuring all documentation meets regulatory requirements.
• Maintain up-to-date records by regularly updating the regulatory database with accurate information on product grouping, risk classification, and registration status.
• Monitor post-market surveillance activities by reviewing logged product complaints and feedback, ensuring prompt follow-up actions are taken according to established procedures.
• Oversee Field Safety Corrective Actions (FSCA) by collaborating with country representatives and distributors to ensure timely closure with relevant authorities.
• Work closely with the Sales Support team to facilitate effective communication and resolution of FSCA-related matters, ensuring all necessary documentation is completed accurately.
• Support preparation for audits such as GDPMDS by participating in audit activities and helping maintain the Quality Management System (QMS) in line with industry standards.
• Assist in editing and reviewing Standard Operating Procedures (SOPs), ensuring they reflect current best practices and regulatory requirements.
• Analyse Voice of Customer (VOC) data and complaints to generate comprehensive QA reports that inform continuous improvement initiatives.
• Participate in cross-country project collaborations, sharing insights and supporting regional harmonisation of regulatory processes.
• Travel within Singapore as needed to legalise documents at embassies or fulfil other ad hoc duties as assigned.

What you bring:

To excel as a Senior Specialist in Regulatory Affairs and Quality Assurance, your background should include hands-on experience navigating complex regulatory environments within the medical device or related industries. Your academic credentials provide a solid foundation for understanding technical requirements while your practical experience ensures you can apply this knowledge effectively under real-world conditions. You bring not only technical acumen but also outstanding communication skills that enable seamless collaboration across departments and regions. Your attention to detail ensures nothing slips through the cracks when it comes to compliance documentation or audit preparation. Adaptability is second nature for youyou remain composed even when juggling multiple tasks or responding to urgent requests. Most importantly, your empathetic approach helps build strong relationships with colleagues at all levels while fostering an atmosphere of mutual respect. Your willingness to learn new skills means youre always ready for fresh meanwhile your passion for quality assurance drives continuous improvement throughout every aspect of your work.

• Hold a degree or diploma in Life Sciences, Engineering, or a related discipline which equips you with foundational knowledge essential for success in this field.
• Have at least one year of relevant experience within the medical device, pharmaceutical, or life sciences industry where you have demonstrated your understanding of regulatory frameworks.
• Demonstrate strong knowledge of regulations governing medical devices including GDPMDS (Good Distribution Practice for Medical Devices), EU Medical Device Directive/Regulation, US FDA guidance, as well as ISO standards such as 13485 and 9001.
• Possess specialised skills in Regulatory Affairs or Quality Assurance (including Quality Control), enabling you to navigate complex compliance landscapes additional specialisation is considered advantageous.
• Exhibit excellent written and verbal communication abilities in English at a professional proficiency level so you can interact confidently with internal teams and external partners alike.
• Show proficiency in Microsoft Office applications which allows you to manage documentation efficiently and present information clearly.
• Display meticulous attention to detail combined with an independent yet co-operative work style that ensures accuracy without sacrificing teamwork.
• Demonstrate adaptability by thriving in fast-paced environments where priorities may shift your ability to multi-task is highly valued here.
• Bring a positive attitude towards learning new concepts while showing genuine enthusiasm for personal development within the regulatory affairs domain.
• Approach challenges proactively with sensitivity towards others perspectivesyour interpersonal skills foster trust among colleagues from diverse backgrounds.

What sets this company apart:

This organisation stands out as a trusted leader within the medical device sector thanks to its unwavering commitment to quality, safety, and ethical business practices. Employees enjoy access to ongoing training opportunities designed to nurture both technical expertise and soft skillsensuring everyone has the tools needed for long-term success. The company fosters an inclusive culture where every voice is collaboration is encouraged not just within teams but also across borders through regular project exchanges. Flexible working arrangements support work-life balance while generous benefits packages reflect genuine care for employee wellbeing. Here youll find yourself surrounded by knowledgeable professionals who are eager to share insightscreating an environment where learning never stops. Whether youre looking for stability or room for advancement within an ever-evolving industry landscape, this employer offers both security today and exciting prospects for tomorrow.

Whats next:

If you are ready to take your career in regulatory affairs and quality assurance further while making a meaningful impact on healthcare outcomes across Southeast Asia, this opportunity awaits your application!

Apply today by clicking on the link providedyour next rewarding career move could be just one step away.

Do note that we will only be in touch if your application is shortlisted.
Robert Walters (Singapore) Pte Ltd
ROC No.: 199706961E | EA Licence No.: 03C5451
EA Registration No.: R1983163 Anarane Thng