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- Tasks: Oversee quality management and regulatory compliance for medical devices.
- Company: Join a dynamic team in Banbury focused on innovative medical solutions.
- Benefits: Enjoy a competitive salary, bonus potential, and flexible working days.
- Why this job: Grow into a leadership role while making a real impact in healthcare.
- Qualifications: Experience in medical device QARA and ISO certification is essential.
- Other info: Opportunity to work closely with strategic partners and regulatory bodies.
The predicted salary is between 34000 - 50000 £ per year.
Location - Banbury, Oxfordshire 2/3 days per week
Salary will be dependent on experience and potentially negotiable for the right person - circa £40k-45k plus bonus and package
Company - The QA/RA manager is a hands-on role with direct responsibility for developing, implementing and enforcing quality management procedures and systems. This role is initially a stand alone in the QARA function (apart from x1 part time assistant). You will be expected to grow in the role and it is likely to become a leadership position.
Key functions:
- Maintain compliance and timely registration for licensing and products associated with the business.
- Identify compliance issues that require follow-up and conduct internal investigation of compliance issues with the aim of continuously looking for process improvements and ruling out non-compliance issues.
- Fully responsible for application, monitoring and process management of multiple ISO certificates and licenses vital to the business.
- Liaise with external suppliers, internal staff and stakeholders and all regulatory bodies.
- In addition to managing the QARA function for in-house manufacturer products, the appointed person will work closely with strategic partners/suppliers to ensure adherence to all standards.
- In this role, the QARA Officer will also be registered as the RESPONSIBLE PERSON.
The perfect candidate will be experienced in medical device QARA and will have ISO experience. They do not need experience as a Responsible Person, but this would be an advantage - as will MDA and CE knowledge.
Skills/qualifications:
- Quality/Regulatory qualification
- Working knowledge of ISO certification
- Effective communication and report writing skills.
- Good negotiation skills with customer-oriented attitude.
- Excellent analytical abilities to grasp the key points from complicated details.
- Good leadership capabilities to lead projects to successful completion.
- Basic knowledge of applicable software to infer statistical data.
- Familiarity with the tools, concepts and methodologies of quality management.
To apply for this - or any of our exciting opportunities in the medical devices sales market - Apply Online.
Quality and Regulatory Officer - Medical Device employer: Progress Sales Recruitment Ltd
Contact Detail:
Progress Sales Recruitment Ltd Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality and Regulatory Officer - Medical Device
✨Tip Number 1
Familiarise yourself with the latest ISO standards relevant to medical devices. Understanding these standards will not only help you in interviews but also demonstrate your commitment to quality and regulatory compliance.
✨Tip Number 2
Network with professionals in the medical device industry, especially those who work in quality assurance and regulatory affairs. Attend industry events or join online forums to gain insights and potentially get referrals.
✨Tip Number 3
Prepare to discuss specific examples of how you've identified compliance issues and implemented process improvements in previous roles. This will showcase your analytical abilities and problem-solving skills during the interview.
✨Tip Number 4
Research the company’s products and their current compliance status. Being knowledgeable about their offerings and any recent news can help you stand out as a candidate who is genuinely interested in the role.
We think you need these skills to ace Quality and Regulatory Officer - Medical Device
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in quality and regulatory roles, particularly in the medical device sector. Emphasise any ISO certification knowledge and specific achievements that demonstrate your compliance management skills.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for quality assurance and regulatory affairs. Mention your understanding of the role's responsibilities and how your background aligns with the company's needs, especially regarding compliance and process improvements.
Highlight Relevant Skills: In your application, clearly outline your effective communication, negotiation skills, and analytical abilities. Provide examples of how you've successfully led projects or improved processes in previous roles to demonstrate your leadership capabilities.
Proofread Your Application: Before submitting, carefully proofread your application materials for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial in a quality and regulatory role.
How to prepare for a job interview at Progress Sales Recruitment Ltd
✨Showcase Your ISO Knowledge
Make sure to highlight your experience with ISO certifications during the interview. Be prepared to discuss specific examples of how you've maintained compliance and managed ISO processes in previous roles.
✨Demonstrate Analytical Skills
Prepare to showcase your analytical abilities by discussing how you've tackled complex compliance issues in the past. Use real-life scenarios to illustrate your problem-solving skills and your approach to continuous improvement.
✨Effective Communication is Key
Since the role involves liaising with various stakeholders, practice articulating your thoughts clearly. Be ready to explain how you’ve effectively communicated compliance requirements and quality management procedures to both technical and non-technical audiences.
✨Leadership Potential
Even if you're not applying for a leadership position right away, demonstrate your leadership capabilities. Share experiences where you've led projects or initiatives, and express your willingness to grow into a leadership role within the QARA function.
