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