Regulatory Affairs Specialist (12 months)

Regulatory Affairs Specialist (12 months) Salary: S$4,200 - S$4,800 per month Location: Singapore Keywords: collaborative, supportive leadership, inclusive, dependable, flexible working opportunities, training opportunities, knowledgeable, generous pensions contributions

A leading organisation in the dental and medical device sector is seeking a Regulatory Affairs Specialist for a 12-month contract based in Singapore. This role offers you the opportunity to be part of a supportive team that values collaboration, knowledge sharing, and professional growth. You will play a pivotal role in ensuring regulatory compliance and maintaining high standards of quality assurance across Southeast Asia. The organisation is committed to providing flexible working opportunities, generous pension contributions, and ongoing training to help you develop your skills further. If you are passionate about making a positive impact in the healthcare industry and thrive in an inclusive environment where your expertise is valued, this position will offer you both challenge and reward.

• Enjoy flexible working arrangements that support your work-life balance while contributing to meaningful projects within the medical device sector.
• Benefit from generous pension contributions and continuous training opportunities designed to nurture your professional development and expand your regulatory expertise.
• Join a knowledgeable, dependable team with supportive leadership that encourages collaboration, inclusivity, and personal growth throughout your tenure.

What you'll do:

As a Regulatory Affairs Specialist, you will be responsible for managing regulatory submissions, product registrations, licence renewals, and amendments across Southeast Asia. Your day-to-day activities will involve classifying products by risk level, keeping databases updated, monitoring post-market surveillance through complaint reviews, and ensuring Field Safety Corrective Actions are completed efficiently.

You will collaborate with country representatives and distributors to close out FSCA cases with local authorities. Supporting audits such as GDPMDS, maintaining QMS systems, editing SOPs, analysing customer feedback for QA reporting, participating in cross-country projects, legalising documents at embassies within Singapore, and handling ad hoc tasks will also form part of your routine. Success in this role requires attention to detail, effective communication skills, adaptability to changing priorities, and a passion for learning within a collaborative environment.

• Coordinate and submit product registration documents promptly for new products, licence renewals, and product amendments across Southeast Asia, ensuring all regulatory requirements are met.
• Classify products according to risk levels and groupings, regularly updating the internal database to maintain accurate records.
• Monitor post-market surveillance activities by reviewing logged product complaints and feedback submitted by the Sales Support team, ensuring timely completion of Field Safety Corrective Actions (FSCA) in accordance with regulations.
• Work closely with country representatives and distributors to facilitate FSCA close-outs with relevant authorities, following up with internal teams as necessary.
• Support audit preparations such as GDPMDS (Good Distribution Practice for Medical Devices), assist in maintaining the Quality Management System (QMS), and provide input on editing and reviewing Standard Operating Procedures (SOPs).
• Analyse Voice of Customer (VOC) data and complaints to generate comprehensive QA reports that inform process improvements.
• Participate in cross-country project collaborations, sharing insights and best practices to enhance regulatory compliance and quality assurance standards.
• Travel within Singapore to embassies for document legalisation as required by regulatory processes.
• Handle ad hoc duties assigned by management, demonstrating adaptability and commitment to organisational goals.

What you bring:

Your proven experience as a Regulatory Affairs Specialist will be instrumental in supporting the organisation’s compliance objectives across Southeast Asia. With a background in life sciences or engineering complemented by hands-on exposure to medical device regulations such as GDPMDS, EU directives/regulations, US FDA guidance, ISO standards 13485 & 9001, you bring valuable insight into submission processes. Your ability to communicate clearly in English—both verbally and in writing—enables seamless coordination between teams.

Proficiency with Microsoft Office tools ensures efficient management of documentation. Meticulousness paired with independence allows you to uphold rigorous quality standards while collaborating effectively on cross-country projects. Your enthusiasm for learning new concepts drives continuous improvement; adaptability empowers you to respond positively when faced with shifting priorities or urgent requests. These qualities make you an ideal fit for this specialist position.

• Degree or Diploma in Life Sciences, Engineering or related discipline provides you with the foundational knowledge required for this specialist role.
• At least one year of relevant experience in regulatory affairs or quality assurance within the medical device, pharmaceutical or life sciences industry enables you to navigate complex compliance requirements.
• Comprehensive understanding of regulations governing medical devices including GDPMDS (Good Distribution Practice for Medical Devices), EU Medical Device Directive/Regulation, US FDA guidance, ISO standards (13485 & 9001) ensures you can manage submissions effectively.
• Specialisation in Regulatory Affairs or Quality Control/Assurance is highly advantageous for addressing industry-specific challenges.
• Excellent communication skills at English proficiency level (both written and conversational) allow you to interact confidently with internal teams and external stakeholders.
• Proficiency in Microsoft Office supports efficient documentation management and reporting responsibilities.
• Meticulous attention to detail combined with an independent yet collaborative approach helps you maintain high standards of accuracy.
• Ability to multi-task effectively while remaining proactive demonstrates your capacity to handle diverse responsibilities under tight deadlines.
• Positive working attitude coupled with a passion for learning fosters continual improvement within the team environment.
• Adaptability in fast-paced settings ensures you remain responsive to evolving regulatory demands.

What sets this company apart:

This organisation stands out as a leader within the dental and medical device sector due to its unwavering commitment to employee development and workplace flexibility. You will join a team that values inclusivity—ensuring every voice is heard—and supportive leadership that nurtures both professional growth and personal well-being. Flexible working opportunities allow you to balance career ambitions with life outside work; generous pension contributions reflect their dedication to long-term financial security.

Training programmes are tailored so you can continually expand your skillset while contributing meaningfully to impactful projects. The company’s culture emphasises collaboration over competition: colleagues share knowledge freely so everyone benefits from collective expertise. By joining this organisation as a Regulatory Affairs Specialist, you become part of an environment where dependability is celebrated alongside innovation—making it an exceptional place for those who value teamwork, learning opportunities, and making a difference within healthcare.

What's next:

If you are ready to take your regulatory affairs career further within an inclusive team that values your expertise—apply now!

Apply today by clicking on the link provided.

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.:R22104739 Siti Aishah Binte Jamall Abd Nassir