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- Tasks: Lead regulatory compliance for medical devices and manage product labeling and complaints.
- Company: Join a global leader in medical device innovation focused on safety and quality.
- Benefits: Enjoy a dynamic work environment with opportunities for growth and global impact.
- Why this job: Make a difference by ensuring products meet global standards and improve patient safety.
- Qualifications: Must have experience in global medical device regulations and ISO 13485 systems.
- Other info: Be part of a team that values detail and proactive problem-solving.
The predicted salary is between 36000 - 60000 £ per year.
Ready to make a global impact? Join our Regulatory Affairs & Quality Assurance team to ensure our products are safe, compliant, and perform as intended across all markets.
As a Regulatory Affairs Manager, you’ll support the Global Head of Regulatory Affairs & Quality Assurance in staying ahead of legislative changes and ensuring compliance. You’ll be the go-to person for keeping our technical files up to date and ensuring our medical device products meet global legislation. You’ll manage product labeling and artwork, assess medical device complaints, and handle customer complaints involving National Authorities. Your keen eye for detail will help us maintain our Quality Management System (ISO 13485) and ensure continuous improvement.
You’ll also be responsible for regulatory intelligence, monitoring changes in medical device legislation, and alerting stakeholders proactively. Your role will involve global product registrations and renewals, reviewing legislation changes, and maintaining our medical device legislation trackers. You’ll work closely with the Compliance Manager to update our approved suppliers list and ensure new suppliers meet our due diligence requirements.
Your expertise will be crucial in advising on legislative changes, speaking with notified bodies and competent authorities, conducting internal audits, and managing product labeling and packaging requirements. You’ll also handle Health Hazard Evaluation Assessment, maintain the artwork master list, and oversee our new materials evaluation process.
To excel in this role, you’ll need previous global medical device and regulatory experience, a solid understanding and application of global medical device legislation and conformity processes for Class I medical devices, and experience with ISO 13485 Quality Management systems and procedures.
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Regulatory Affairs Manager employer: Specsavers
Contact Detail:
Specsavers Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Manager
✨Tip Number 1
Familiarize yourself with the latest global medical device regulations and ISO 13485 standards. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in a rapidly changing field.
✨Tip Number 2
Network with professionals in the regulatory affairs community. Attend industry conferences or webinars to connect with others in the field, which can provide valuable insights and potentially lead to referrals for job openings.
✨Tip Number 3
Prepare to discuss specific examples of how you've managed compliance issues or improved quality management systems in your previous roles. Real-life scenarios can showcase your problem-solving skills and expertise.
✨Tip Number 4
Stay proactive about understanding the company's products and their market positioning. Being knowledgeable about our offerings will allow you to speak confidently about how you can contribute to our regulatory affairs team.
We think you need these skills to ace Regulatory Affairs Manager
Some tips for your application 🫡
Understand the Role: Take the time to thoroughly read the job description for the Regulatory Affairs Manager position. Understand the key responsibilities and required qualifications, so you can tailor your application accordingly.
Highlight Relevant Experience: In your CV and cover letter, emphasize your previous experience in global medical device regulation and compliance. Be specific about your familiarity with ISO 13485 and any relevant legislation you've worked with.
Showcase Attention to Detail: Given the importance of detail in regulatory affairs, provide examples in your application that demonstrate your keen eye for detail. This could include past projects where you successfully managed compliance or quality assurance tasks.
Express Your Proactive Approach: Mention instances where you proactively monitored legislative changes or improved processes in your previous roles. This will show that you are not only reactive but also forward-thinking, which is crucial for this position.
How to prepare for a job interview at Specsavers
✨Show Your Regulatory Knowledge
Be prepared to discuss your understanding of global medical device legislation and ISO 13485. Highlight specific examples from your past experience where you successfully navigated regulatory challenges.
✨Demonstrate Attention to Detail
Since this role requires a keen eye for detail, share instances where your attention to detail made a significant impact on compliance or quality management. This will showcase your suitability for maintaining technical files and product labelling.
✨Stay Updated on Legislation Changes
Research recent changes in medical device regulations before the interview. Being able to discuss current trends and how they might affect the company will demonstrate your proactive approach and commitment to regulatory affairs.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills in real-world scenarios, such as handling customer complaints or conducting internal audits. Prepare structured responses that highlight your analytical thinking and decision-making process.
