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- Tasks: Support regulatory activities and ensure compliance for medical devices and IVDs.
- Company: Join a leading company in the medical device industry with a focus on quality.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on continuous improvement and training.
- Why this job: Make a difference in healthcare by ensuring product safety and compliance.
- Qualifications: Bachelor’s degree in Life Sciences or related field; 2 years of relevant experience.
The predicted salary is between 30000 - 40000 £ per year.
Support regulatory activities, including preparation and submission of product registrations for medical devices and IVDs to HSA and other regulatory authorities (e.g. EU IVDR, FDA). Assist in ensuring compliance with applicable regulatory requirements and standards across all markets. Support post-market regulatory activities, including product renewals, vigilance reporting, and change notifications.
Assist in maintaining and improving the Quality Management System (QMS) in accordance with ISO 13485, GDPMDS, and other applicable standards. Ensure quality processes and documentation are aligned with regulatory requirements. Prepare, review, and maintain quality and regulatory documentation, including SOPs, work instructions, and records.
Support internal and external audits (e.g. regulatory inspections, certification audits), including audit preparation and follow-up on corrective and preventive actions (CAPA). Coordinate with cross-functional teams (e.g. R&D, Operations, Supply Chain) and suppliers to ensure compliance with regulatory and quality requirements. Provide support on regulatory and quality matters to internal stakeholders when required. Assist in conducting training on regulatory and quality topics. Support continuous improvement initiatives for QMS and regulatory compliance processes.
Job Requirements
- Bachelor’s degree in Life Sciences, Biotechnology, Biomedical Engineering, or a related field.
- At least 2 years of relevant experience in Regulatory Affairs and/or Quality Assurance within the medical device or IVD industry.
- Basic knowledge of HSA regulations, ISO 13485, GDPMDS, and familiarity with EU IVDR and FDA QSR.
- Exposure to regulatory submissions and product registration is an advantage.
- Understanding of QMS processes, documentation control, and CAPA is preferred.
- Good organizational, communication, and coordination skills.
Regulatory Affairs & Quality Assurance Executive employer: Consortium for Clinical Research and Innovation Singapore
Contact Detail:
Consortium for Clinical Research and Innovation Singapore Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs & Quality Assurance Executive
✨Tip Number 1
Network like a pro! Reach out to professionals in the Regulatory Affairs and Quality Assurance field on LinkedIn. Join relevant groups and participate in discussions to get your name out there and learn about potential job openings.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of HSA regulations, ISO 13485, and other standards mentioned in the job description. We recommend creating a cheat sheet with key points to discuss during your interview.
✨Tip Number 3
Don’t just apply and wait! Follow up on your applications after a week or so. A quick email expressing your continued interest can set you apart from other candidates and show your enthusiasm for the role.
✨Tip Number 4
Utilise our website to find roles that match your skills. We’ve got a range of opportunities in Regulatory Affairs and Quality Assurance that could be perfect for you. Don’t miss out on applying directly through us!
We think you need these skills to ace Regulatory Affairs & Quality Assurance Executive
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Affairs & Quality Assurance role. Highlight your relevant experience in regulatory submissions and quality management systems, especially if you've worked with ISO 13485 or similar standards.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory affairs and how your background aligns with our needs. Don’t forget to mention any specific experiences that relate to HSA regulations or FDA QSR.
Showcase Your Teamwork Skills: Since this role involves coordinating with cross-functional teams, make sure to highlight your teamwork and communication skills. Share examples of how you've successfully collaborated with others in past roles, especially in a regulatory context.
Apply Through Our Website: We encourage you to apply through our website for the best chance of getting noticed. It’s super easy, and you’ll be able to keep track of your application status directly!
How to prepare for a job interview at Consortium for Clinical Research and Innovation Singapore
✨Know Your Regulations
Make sure you brush up on the specific regulations relevant to the role, like HSA, ISO 13485, and EU IVDR. Being able to discuss these confidently will show that you're not just familiar with the terms but understand their implications in real-world scenarios.
✨Showcase Your Experience
Prepare examples from your past work that highlight your experience in regulatory affairs and quality assurance. Think about specific projects where you handled product registrations or compliance issues, and be ready to explain your role and the outcomes.
✨Demonstrate Cross-Functional Collaboration
Since this role involves coordinating with various teams, be prepared to discuss how you've successfully worked with R&D, Operations, or Supply Chain in the past. Share instances where your collaboration led to improved compliance or efficiency.
✨Ask Insightful Questions
At the end of the interview, don’t shy away from asking questions. Inquire about the company’s approach to continuous improvement in QMS or how they handle regulatory changes. This shows your genuine interest in the role and helps you gauge if it’s the right fit for you.