At a Glance
- Tasks: Lead regulatory submissions and support quality management system implementation for innovative medical devices.
- Company: Dynamic consultancy focused on software as a medical device projects.
- Benefits: Flexible rates, remote work, and potential contract extensions.
- Other info: Join a fast-paced environment with opportunities to grow your expertise.
- Why this job: Make a real impact in the healthcare tech space while working remotely.
- Qualifications: Experience with CE marked and FDA-authorised products, plus strong knowledge of relevant standards.
The predicted salary is between 50000 - 60000 € per year.
We're seeking an experienced QARA Consultant to work on multiple SaMD and AIaMD projects on quality and regulatory activities. You'll own end-to-end regulatory submissions (CE & FDA), support QMS implementation.
Key requirements:
- Proven experience with CE marked & FDA-authorised SaMD/AIaMD products
- Strong knowledge of ISO 13485, ISO 14971, IEC 62304/82304/62366
- Confident leading submissions, client engagements, and multiple projects
What's on offer:
- Possible extensions
- Flexible rate
- Remote working
Software QARA Consultant in Brockley employer: Computer Futures
At Computer Futures, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters innovation and collaboration. Our remote working model provides flexibility, allowing you to balance your professional and personal life while engaging in meaningful projects within the medical device sector. With opportunities for professional growth and a supportive team environment, we are committed to helping our employees thrive in their careers.
StudySmarter Expert Advice🤫
We think this is how you could land Software QARA Consultant in Brockley
✨Tip Number 1
Network like a pro! Reach out to your connections in the medical device industry and let them know you're on the lookout for QARA roles. You never know who might have a lead or can put in a good word for you.
✨Tip Number 2
Show off your expertise! When you get the chance to chat with potential employers, be ready to discuss your experience with CE marked and FDA-authorised products. Highlight specific projects where you've led submissions or implemented QMS.
✨Tip Number 3
Stay updated on industry trends! Follow relevant blogs, join forums, and participate in webinars related to SaMD and AIaMD. This will not only boost your knowledge but also give you great talking points during interviews.
✨Tip Number 4
Apply through our website! We’ve got loads of opportunities that match your skills. Plus, applying directly gives you a better chance of standing out to recruiters who are looking for someone just like you.
We think you need these skills to ace Software QARA Consultant in Brockley
Some tips for your application 🫡
Tailor Your CV:Make sure your CV highlights your experience with CE marked and FDA-authorised SaMD/AIaMD products. We want to see how your skills align with the role, so don’t be shy about showcasing relevant projects you've worked on!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re the perfect fit for this QARA Consultant role. Mention your knowledge of ISO standards and any specific experiences that relate to the job description.
Showcase Your Leadership Skills:Since you'll be leading submissions and client engagements, make sure to highlight any past experiences where you’ve taken charge. We love seeing candidates who can confidently manage multiple projects!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates regarding your application status!
How to prepare for a job interview at Computer Futures
✨Know Your Regulations
Make sure you brush up on the key regulations like ISO 13485 and IEC 62304 before your interview. Being able to discuss these standards confidently will show that you’re not just familiar with them, but that you can apply them in real-world scenarios.
✨Showcase Your Experience
Prepare specific examples from your past work where you successfully led regulatory submissions for CE marked or FDA-authorised products. This will help demonstrate your hands-on experience and ability to manage multiple projects effectively.
✨Engage with Questions
Don’t hesitate to ask insightful questions about the company’s current SaMD and AIaMD projects. This shows your genuine interest in their work and helps you understand how you can contribute to their goals.
✨Highlight Your Flexibility
Since this role offers remote working and possible extensions, be ready to discuss your adaptability and how you manage your time effectively while working remotely. This will reassure them that you can thrive in a flexible work environment.
