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- Tasks: Lead regulatory compliance and quality assurance for medical devices.
- Company: Join a dynamic team focused on innovative healthcare solutions.
- Benefits: Enjoy flexible working options and a supportive work culture.
- Why this job: Make a real impact on patient safety and product quality.
- Qualifications: Bachelor's degree and 5 years in QA/RA within the medical device sector.
- Other info: Opportunity to collaborate with cross-functional teams and lead audits.
The predicted salary is between 36000 - 60000 £ per year.
Job Title: QA/RA Manager Key Responsibilities: Regulatory Compliance and Quality Assurance: · Ensure compliance with EU MDR 2017/745, FDA QSR, ISO 13485, and ISO 14971 standards. · Oversee the maintenance and improvement of the Quality Management System (QMS). · Lead activities related to regulatory submissions, including technical file preparation and updates. · Act as the primary point of contact for regulatory inspections and audits. · Provide guidance on risk management processes in line with ISO 14971 to ensure patient safety. · Monitor changes in regulations and implement necessary updates to processes and documentation. Quality Systems Development: · Develop and maintain quality engineering methodologies to ensure product compliance. · Support post-market surveillance activities, including adverse event reporting and vigilance. · Lead internal and supplier audits, ensuring effective corrective and preventive actions (CAPA). · Collaborate with cross-functional teams to ensure compliance throughout the product lifecycle. · Measure and improve the quality of internal and external components and suppliers. Project Support: · Support design and development teams with quality and regulatory guidance. · Ensure proper execution of design control and validation activities for new and existing products. · Provide input on usability and human factors engineering to meet regulatory expectations. · Lead the creation and implementation of post-market surveillance plans. Qualifications and Skills: · Bachelor\’s degree in Engineering, Quality Assurance, Regulatory Affairs, or a related field. · 5 years of experience in a QA/RA role within the medical device industry. · In-depth knowledge of EU MDR, ISO 13485, ISO 14971, and related regulatory standards. · Proven experience managing QMS in a regulated environment. · Strong understanding of risk management principles and regulatory submissions. · Excellent analytical, organizational, and communication skills. · Ability to lead and influence cross-functional teams. · Experience with regulatory inspections and audits is a plus.41bf1e1f-b16b-4260-a40a-17c77a06fd15
Regulatory Affairs Manager employer: Meet Life Sciences
Contact Detail:
Meet Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Manager
✨Tip Number 1
Familiarise yourself with the latest updates on EU MDR and FDA regulations. Being well-versed in these standards will not only boost your confidence during interviews but also demonstrate your commitment to staying current in the field.
✨Tip Number 2
Network with professionals in the regulatory affairs and quality assurance sectors. Attend industry conferences or webinars to connect with others who can provide insights into the role and potentially refer you to opportunities at companies like us.
✨Tip Number 3
Prepare to discuss specific examples of how you've managed QMS and handled regulatory submissions in your previous roles. Real-life scenarios will help illustrate your expertise and problem-solving skills to potential employers.
✨Tip Number 4
Research our company culture and values at StudySmarter. Tailoring your approach to align with our mission and demonstrating how your experience fits within our framework can make a significant impact during the interview process.
We think you need these skills to ace Regulatory Affairs Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in regulatory affairs and quality assurance, particularly within the medical device industry. Emphasise your knowledge of EU MDR, ISO 13485, and ISO 14971 standards.
Craft a Strong Cover Letter: Write a cover letter that specifically addresses the key responsibilities listed in the job description. Mention your experience with regulatory submissions, QMS management, and any relevant audits you've led.
Showcase Your Skills: In your application, clearly demonstrate your analytical, organisational, and communication skills. Provide examples of how you've successfully led cross-functional teams or managed compliance projects.
Highlight Continuous Learning: Mention any ongoing education or certifications related to regulatory affairs or quality assurance. This shows your commitment to staying updated with industry standards and regulations.
How to prepare for a job interview at Meet Life Sciences
✨Know Your Regulations
Familiarise yourself with the EU MDR 2017/745, FDA QSR, ISO 13485, and ISO 14971 standards. Be prepared to discuss how your experience aligns with these regulations and how you have ensured compliance in previous roles.
✨Showcase Your QMS Experience
Highlight your experience in managing Quality Management Systems. Discuss specific examples of how you've maintained and improved QMS in a regulated environment, and be ready to explain the methodologies you used.
✨Demonstrate Cross-Functional Collaboration
Prepare to talk about your experience working with cross-functional teams. Share examples of how you've collaborated with design and development teams to ensure compliance throughout the product lifecycle.
✨Be Ready for Scenario Questions
Expect scenario-based questions related to regulatory submissions and audits. Think of situations where you had to lead a regulatory inspection or manage a CAPA process, and be ready to explain your approach and outcomes.
