Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Lead regulatory compliance and quality assurance for medical devices.
- Company: Join a dynamic team dedicated to improving patient safety through innovative medical solutions.
- Benefits: Enjoy flexible working options, professional development opportunities, and a supportive work culture.
- Why this job: Make a real impact in healthcare while collaborating with diverse teams and enhancing your skills.
- Qualifications: Bachelor's degree and 5+ years in QA/RA within the medical device sector required.
- Other info: Experience with regulatory inspections is a bonus!
The predicted salary is between 43200 - 72000 £ per year.
Job Description
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.
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 community. Attend industry conferences or webinars where you can meet people who work in similar roles. This can lead to valuable insights and potential referrals for the position at StudySmarter.
✨Tip Number 3
Prepare to discuss specific examples of how you've successfully managed QMS and regulatory submissions in your previous roles. Highlighting your hands-on experience will set you apart from other candidates.
✨Tip Number 4
Research StudySmarter's products and services thoroughly. Understanding our mission and how regulatory compliance plays a role in our success will allow you to tailor your conversation during the interview, showing that you're genuinely interested in joining our team.
We think you need these skills to ace Regulatory Affairs Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your 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 Compelling Cover Letter: Write a cover letter that specifically addresses the key responsibilities outlined in the job description. Use examples from your past experience to demonstrate how you meet these requirements and your ability to lead cross-functional teams.
Showcase Relevant Skills: In your application, clearly outline your analytical, organisational, and communication skills. Provide specific examples of how you've successfully managed QMS and handled regulatory submissions in previous roles.
Proofread Your Application: Before submitting, carefully proofread your application for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial in regulatory affairs.
How to prepare for a job interview at Meet Life Sciences
✨Know Your Regulations
Make sure you have a solid understanding of EU MDR 2017/745, FDA QSR, ISO 13485, and ISO 14971. Be prepared to discuss how these regulations impact your previous roles and how you've ensured compliance in the past.
✨Showcase Your QMS Experience
Highlight your experience with Quality Management Systems. Be ready to provide examples of how you've maintained and improved QMS in your previous positions, and discuss any specific methodologies you've developed.
✨Prepare for Scenario Questions
Expect scenario-based questions that assess your problem-solving skills in regulatory affairs. Think of situations where you've had to lead audits or manage CAPA processes, and be ready to explain your approach and outcomes.
✨Demonstrate Cross-Functional Collaboration
Since this role involves working with various teams, prepare to discuss how you've successfully collaborated with design and development teams in the past. Share specific examples of how your guidance has influenced product compliance and safety.
