Regulatory Affairs Consultant
Posted 6 days ago by Storke
Negotiable
Undetermined
Remote
London Area, United Kingdom
Summary: This role is for a part-time Regulatory Affairs Consultant at Storke, a company specializing in AI solutions for Medical Device Regulatory Affairs. The consultant will work remotely, focusing on reviewing submission documents for MHRA Class I and Class IIa/IIb, ensuring they meet industry standards. The position requires less than 10 hours of work per month and offers flexible working arrangements. The role emphasizes quality assurance rather than document creation.
Key Responsibilities:
- Refine submission documents for regulatory compliance.
- Ensure documentation quality meets industry standards.
- Focus on MHRA Class I and Class IIa/IIb submissions.
- Review documents rather than create them.
Key Skills:
- Skills in Regulatory Compliance, Regulatory Requirements, and Regulatory Affairs.
- Experience managing MHRA Class I, IIa/IIb submissions; Class III is a plus.
- Project Management skills.
- Excellent attention to detail and analytical skills.
- Ability to work collaboratively and meet deadlines.
- Experience in the healthcare or pharmaceutical industry is a plus.
Salary (Rate): undetermined
City: London Area
Country: United Kingdom
Working Arrangements: remote
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
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