Regulatory Affairs (Remote, Medical Device)

A leading global medical device organisation is seeking a Regulatory Affairs Specialist to join their remote team, supporting Australasia and Southeast Asia. This role offers the unique opportunity to work from anywhere while contributing to the advancement of healthcare standards across multiple countries. You will be part of a supportive network that values knowledge sharing, professional development, and inclusive collaboration.

What you'll do:

As a Regulatory Affairs Specialist – Medical Device (Remote), you will play a pivotal role in ensuring that products meet stringent regulatory requirements across Australasia and Southeast Asia. Your day-to-day responsibilities will involve coordinating timely submissions for product registrations, renewals, and amendments while keeping databases current. You will monitor post-market surveillance activities by reviewing feedback logged by sales support teams, ensuring that corrective actions are completed efficiently. Collaboration is key; you will work closely with country representatives, distributors, and local authorities to facilitate regulatory processes. Supporting audit preparations such as GDPMDS audits will be part of your routine, along with maintaining the QMS system through SOP reviews. Analysing customer feedback will enable you to create insightful QA reports that drive improvements. You will also participate in cross-country projects, sharing knowledge within a communal network. Your adaptability will be tested as you take on ad hoc tasks assigned by management. Success in this role requires attention to detail, responsiveness, excellent interpersonal skills, and a passion for learning within a supportive environment.

• Coordinate and submit product registration documents promptly for new products, license renewals, and amendments, including product grouping, risk classification, and regular database updates.
• Monitor post-market surveillance activities by reviewing logged product complaints and feedback in the system, ensuring Field Safety Corrective Actions (FSCA) are completed efficiently according to regulations.
• Work closely with country representatives and distributors to facilitate FSCA close-outs with local authorities, following up with sales support teams as needed.
• Support audit preparations such as GDPMDS and help maintain the Quality Management System (QMS), providing assistance in editing and reviewing Standard Operating Procedures (SOPs).
• Analyse Voice of Customer (VOC) data and complaints to generate comprehensive Quality Assurance reports that inform process improvements.
• Participate in cross-country project collaborations, sharing insights and best practices with colleagues across different regions.
• Assist in any other ad hoc duties assigned by management, demonstrating flexibility and willingness to contribute wherever needed.
• Ensure compliance with relevant regulatory requirements for medical devices by staying updated on evolving standards such as EU Medical Device Directive/Regulation, US FDA guidance, ISO 13485, ISO 9001.
• Provide dependable support during audits by preparing documentation and facilitating communication between internal teams and external auditors.
• Maintain meticulous records of regulatory submissions, product changes, and corrective actions to ensure transparency and traceability.

What you bring:

The ideal candidate for the Regulatory Affairs Specialist – Medical Device (Remote) role brings proven experience from the medical device or life sciences sector. Your educational background equips you with foundational knowledge necessary for understanding complex regulations. Experience handling regulatory submissions ensures you can navigate compliance requirements confidently. Familiarity with international standards such as GDPMDS, EU directives, US FDA guidance, ISO 13485/9001 enables you to support quality assurance initiatives effectively. Your strong communication skills allow you to connect with colleagues across borders while managing documentation accurately using Microsoft Office tools. Attention to detail is crucial when analysing customer feedback or preparing audit materials. Adaptability helps you thrive amidst shifting priorities while your positive attitude fuels ongoing learning. Collaborative spirit ensures successful participation in cross-country projects where communal support drives shared success.

• Degree or Diploma in Life Sciences, Engineering or related discipline is required for this position.
• At least one year of relevant experience in regulatory affairs within the medical device, pharmaceutical or life sciences industry is preferred.
• Good knowledge of regulations governing medical devices including GDPMDS (Good Distribution Practice for Medical Devices), EU Medical Device Directive/Regulation, US FDA guidance, ISO 13485 and ISO 9001 standards is essential.
• Specialisation in Regulatory Affairs or Quality Assurance (Quality Control/Assurance) is considered an advantage for this role.
• Excellent communication skills with proficiency in English for both written correspondence and conversational interactions are necessary.
• Proficiency in Microsoft Office applications is required for effective documentation management.
• Meticulous attention to detail combined with a proactive approach ensures accuracy in regulatory submissions and surveillance activities.
• Ability to multi-task efficiently while maintaining high standards under fast-paced conditions demonstrates adaptability.
• Positive working attitude coupled with enthusiasm for learning supports ongoing professional development within the team.
• Capacity to collaborate effectively across countries fosters communal knowledge sharing.

What sets this company apart:

This organisation stands out as a global leader dedicated to advancing healthcare standards through innovative medical devices. Employees enjoy flexible working opportunities that empower them to balance personal commitments alongside professional responsibilities. The company’s commitment to inclusivity means every voice is heard within its supportive network—whether collaborating on projects or sharing insights during training sessions. Generous pensions contributions reflect their investment in long-term employee wellbeing while continuous training opportunities foster growth leadership at every stage of your career journey. With knowledgeable colleagues ready to share expertise across regions, you’ll find yourself part of an environment where communal achievement is celebrated. The focus on nurturing talent ensures that each team member feels valued as they contribute towards improving patient outcomes worldwide.

What's next:

If you are ready to make a difference in regulatory affairs within the medical device sector while enjoying flexible remote working arrangements—apply now!

Apply today by clicking on the link provided.

Do note that we will only be in touch if your application is shortlisted.

Agensi Pekerjaan Robert Walters Sdn Bhd
Business Registration Number : 729828-T
Licence Number : JTKSM 423C