Regulatory Affairs Specialist
2 weeks ago
**About Mirada Medical...**
Mirada Medical develops medical imaging and cancer treatment planning solutions that provide simple and accessible solutions to complex image analysis problems in the diagnosis and treatment of cancer and other diseases. Our solutions interoperate with other IT systems in the healthcare enterprise, such as EHRs and PACS, empowering users to access our clinical solutions when and where appropriate and to exchange data. Our treatment planning solutions improve consistency and productivity while enabling clinicians to deliver more personalised care. By combining deep learning technology with our thorough understanding of the challenges faced in oncology today, Mirada is leading the development of next generation imaging software and decision support products. Our staff are passionate about using their expertise to help our customers provide better healthcare for more patients.
**Do you want to work somewhere with real purpose in life saving technologies? Are you a Regulatory Affairs Specialist with a keen interest in healthcare and medical software? This is your opportunity to join the Mirada team**
**The Regulatory Affairs and Quality Assurance Quality (RAQA)** **department is part of Product and supports the company at a corporate level and regionally in both the UK and the US. With the support of the Senior Management Team and Board of Directors,** t**he RAQA department ensures that the company complies with regulatory requirements in all applicable global regions and supports the company to meet the required quality standards and objectives in all areas of the business.**
The **Regulatory affairs specialist** reports to the Head of RA QA and** has responsibility for**:
- Managing new and existing regional product registrations and licenses
- Assisting in-country representatives with regulatory submissions
- Compiling product technical files and other regulatory documentation
- Advising product teams on regulatory requirements for different countries/regions
- Identifying and assessing new and changed regulatory requirements
- Create RA project deliverables to support the project phase reviews
- Process owner as RA Quality Management System (QMS) Lead for Regulatory Standard Operating Procedure (SOPs)
- Marketing claims review for different stakeholders
- Complaints review and post-market surveillance
- Support external audits on regulatory requirements
**The main duties and responsibilities of the role are...**
- Creating submission documentation for submission to regulators/reviewers (e.g., FDA 510(k), EU NB Technical File).
- Liaising with regulators/reviewers to resolve questions or issues with technical documentation.
- Working with Head of RAQA to develop regulatory strategy for new territories and new products.
- Working with Head of RAQA to support planning of product features and release.
- Ensuring and supporting correct completion of required technical documentation during product development, e.g., Risk Management File, Usability Engineering File, Cybersecurity documentation.
- Review of product technical documentation during product development.
- Post-market surveillance specialist to review cases and escalate them as complaints to DHB or HRB meetings or report to regulatory bodies if required.
- Conduct regular PMS-IT meetings to review cybersecurity vulnerabilities and end of life actions.
- Conduct monthly global regulatory intelligence update to identify and assess new regulatory requirements in existing territories and updating procedures to keep them current.
- In-country representative (ICR) and Economic Operator (EO) initial supplier evaluation.
- Handling RA related CAPAs.
- Participating in meetings with partner companies and update regulatory status, provide a strategy to enter new markets as required and facilitate registrations.
- Checking product and marketing claims.
- Ownership and maintenance of RA-related procedures, templates and guidance documents and conducting periodic document review.
- Production of product clinical documentation (CEP, CER, PMCFP, PMCFR) as required.
- Production of product post-market surveillance documentation (PMSP, PMSR, PSUR) as required.
- Chairing meeting to review complaints escalated as presenting a hazard.
- Reporting reportable events to regulatory authorities.
- Deputising for and supporting other RAQA team members as required.
**We are looking for the following skills and competencies...**
**Essential**
- Prior experience of working for a medical device company in a regulatory role
- Ability to understand technical documentation such as product requirements and test specifications
- Excellent written and verbal communication skills at all levels
- Compiling regulatory submissions for medical devices
- Superb attention to detail
**Advantageous**
- Qualification in regulatory affairs or quality assurance.
- Prior experience working for a **software **medical device company.
- Understanding of Medical Devi
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