At a Glance
- Tasks: Review and refine regulatory submission documents for medical devices.
- Company: Join Storke, a leader in AI-driven regulatory affairs for medical devices.
- Benefits: Generous hourly compensation, flexible remote work, and minimal time commitment.
- Why this job: Make a real impact in healthcare by ensuring compliance and accelerating innovation.
- Qualifications: Experience with MHRA submissions and strong attention to detail required.
- Other info: Part-time role with less than 10 hours of work per month.
Company Description
Storke hosts AI agents for Medical Device Regulatory Affairs; designed to automate the most taxing workflows for medical device companies. Our AI agents handle documentation, submissions, and compliance tracking, reducing months of manual effort to accelerate time-to-market. By transforming regulatory affairs from bottleneck to competitive advantage, Storke enables companies to focus on innovation whilst ensuring stringent compliance standards are met.
Role Description
This is a contractual (3 Month) part-time role that is remote for a Regulatory Affairs Consultant.
This is a very flexible role, requiring less than 10 hours of work per month.
The Regulatory Affairs Consultant will be responsible for refining submission documents, whilst ensuring the quality of documentation is of industry standard. Clear focus will currently be on MHRA Class I, Class IIa/IIb submissions.
**Please note that you will not be writing or creating documents, but reviewing them**
**Generous compensation for time spent, we bill hourly!**
Qualifications
- Skills in Regulatory Compliance, Regulatory Requirements, and Regulatory Affairs
- Experience in primarily managing MHRA Class I,IIa/IIb submissions, Class III is a plus but not a necessity
- Project Management skills
- Excellent attention to detail and analytical skills
- Ability to work collaboratively
- Ability to meet deadlines
- Experience in the healthcare or pharmaceutical industry is a plus
Regulatory Affairs Consultant employer: Storke
Contact Detail:
Storke Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Consultant
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs space on LinkedIn or industry forums. We can leverage our connections to get insights and maybe even referrals that could land us an interview.
✨Tip Number 2
Prepare for virtual interviews by practising common questions related to regulatory compliance and submissions. We should also have examples ready that showcase our attention to detail and project management skills.
✨Tip Number 3
Stay updated on the latest regulations and trends in medical device compliance. We can impress potential employers by discussing recent changes during interviews, showing that we’re proactive and knowledgeable.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we can tailor our approach based on the specific needs of Storke, making us stand out.
We think you need these skills to ace Regulatory Affairs Consultant
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your application to highlight your experience with MHRA submissions. We want to see how your skills align with the role, so don’t be shy about showcasing your relevant expertise!
Show Off Your Attention to Detail: Since this role requires a keen eye for quality documentation, we recommend including examples of how you've ensured accuracy in past projects. This will help us see that you’re the right fit for maintaining our high standards.
Keep It Concise: We appreciate clarity and brevity! When writing your application, stick to the point and avoid fluff. Highlight your key achievements and skills that relate directly to the role.
Apply Through Our Website: Don’t forget to submit your application through our website! It’s the best way for us to receive your details and ensures you’re considered for the role. We can’t wait to hear from you!
How to prepare for a job interview at Storke
✨Know Your Regulations
Make sure you brush up on the specifics of MHRA Class I, IIa, and IIb submissions. Familiarise yourself with the latest guidelines and compliance standards, as this will show your expertise and readiness to tackle the role.
✨Showcase Your Attention to Detail
Since the role involves reviewing documents, be prepared to discuss examples where your attention to detail made a difference. Bring up specific instances where you caught errors or improved documentation quality in previous roles.
✨Demonstrate Collaborative Skills
This position requires working collaboratively, so think of examples that highlight your teamwork abilities. Be ready to share how you've successfully worked with others in regulatory affairs or similar environments.
✨Prepare Questions About the Role
Have a few thoughtful questions ready about the role and the company’s approach to regulatory affairs. This shows your genuine interest and helps you understand how you can contribute effectively to their mission.