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- Tasks: Support quality management and regulatory compliance for medical devices.
- Company: Join an innovative Oxford-based startup in the medical device industry.
- Benefits: Competitive salary, opportunity for growth, and a chance to make an impact.
- Why this job: Be part of a mission-driven team focused on improving healthcare through quality assurance.
- Qualifications: Bachelor’s degree in life sciences; experience in document control preferred.
- Other info: No special working conditions; flexible and supportive work environment.
The predicted salary is between 30000 - 36000 £ per year.
1. Job purpose
The purpose of the Regulatory Affairs and Quality Assurance Associate is to support the Regulatory and Quality department in the maintenance, management and development of the Company’s quality management system ensuring product and procedural compliance to ISO13485: 2016, FDA and EU MDR Regulatory requirements.
2. Duties and responsibilities
- Ensure compliance throughout the document/record lifecycle: including the creation, approval, issuance, revision, retention, timely retrieval during audits, and obsoletion.
- Provide oversight of the document periodic review program and ensure status is conveyed to internal stakeholders.
- Support Document Control and Change Management by tracking requested revisions and ensuring internal teams are apprised of changes and that implementation dates are met.
- Proactively identify opportunities for process improvements, automation, and efficiency gains in the document control function.
- Update and maintain complete and accurate regulatory compliance records including Non-conformances (NCs), Corrective & Preventative Actions (CAPA).
- Update and maintain complete and accurate Quality Management System and Health and Safety Employee and New Hire Training requirements.
- Maintain organized files for all regulatory documents and data.
- Assist with Clinical Investigation submissions
- Provide support on other RA/QA projects when necessary
- Perform other duties as assigned
3. Qualifications
- Bachelor’s Degree required; life science or related field, preferred
- Experience with document control management systems, Greenlight Guru experience preferred.
- Strong foundational knowledge in Good Documentation Practice (GDP) per ISO13485: 2016
- Knowledge of current Good Clinical Practice (cGMP) for Medical Devices per ISO14155: 2020
- 2+ years of relevant experience in document control/record control (including standard process creation and implementation); biotech, pharma, drug product, or medical device document control experience preferred
4. Working conditions
The job does not require the person to work in special working conditions.
5. Physical requirements
The job is not physically demanding and does not have any no specific physical requirements.
Salary Range; £30,000-£36,000 depending on experience
QA/RA Associate for an Oxford based medical device startup employer: Oxford Endovascular Ltd
Contact Detail:
Oxford Endovascular Ltd Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land QA/RA Associate for an Oxford based medical device startup
✨Tip Number 1
Familiarize yourself with ISO13485:2016 and FDA regulations. Understanding these standards will not only help you in the interview but also demonstrate your commitment to quality assurance and regulatory compliance.
✨Tip Number 2
Gain hands-on experience with document control management systems, especially Greenlight Guru if possible. Highlight any relevant projects or experiences where you successfully managed documentation processes.
✨Tip Number 3
Showcase your ability to identify process improvements. Prepare examples of how you've previously streamlined document control or quality assurance processes, as this aligns with the role's focus on efficiency gains.
✨Tip Number 4
Network with professionals in the medical device industry. Attend relevant webinars or local meetups to connect with others in regulatory affairs and quality assurance, which could lead to valuable insights and potential referrals.
We think you need these skills to ace QA/RA Associate for an Oxford based medical device startup
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description and understand the key responsibilities and qualifications required for the QA/RA Associate position. Tailor your application to highlight relevant experiences.
Highlight Relevant Experience: In your CV and cover letter, emphasize your experience with document control management systems and any familiarity with ISO13485: 2016, FDA, and EU MDR requirements. Use specific examples to demonstrate your expertise.
Showcase Process Improvement Skills: Mention any past experiences where you identified opportunities for process improvements or automation in document control functions. This will show your proactive approach and problem-solving skills.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any errors or inconsistencies. A well-presented application reflects your attention to detail, which is crucial for a QA/RA role.
How to prepare for a job interview at Oxford Endovascular Ltd
✨Understand Regulatory Standards
Make sure you have a solid grasp of ISO13485:2016, FDA, and EU MDR requirements. Be prepared to discuss how your previous experiences align with these standards and how you can ensure compliance in the role.
✨Showcase Document Control Experience
Highlight your experience with document control management systems, especially if you've used Greenlight Guru. Be ready to provide examples of how you've managed document lifecycles and ensured compliance in past roles.
✨Emphasize Process Improvement Skills
Demonstrate your ability to identify opportunities for process improvements and efficiency gains. Share specific instances where you've successfully implemented changes that enhanced document control functions.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills in real-world scenarios related to regulatory compliance and quality assurance. Practice articulating your thought process and decision-making strategies in these situations.
