Key Responsibilities
* Support quality, regulatory, and compliance matters within the QCRS team.
* Manage ongoing maintenance of regulatory requirements to ensure compliance with contractual and regulatory obligations.
* Provide best practice in quality management systems (QMS).
Key Duties and Responsibilities:
* This job description is not an exhaustive list of duties for the position holder.
* It does, however, provide an indication of the main duties and responsibilities of the position.
Duties and Responsibilities Overview
* Responsibility for identifying regulatory requirements within Medical Device Regulation.
* Understanding legislation and applying it to each business.
* Review and approval of regulatory documentation for new vendors and product setup.
* Recording and monitoring of product classification and identification of any registration or licensing requirements.
* Overseeing and managing inbound queries from suppliers, customers, internal stakeholders, and competent authorities.
* Contributing to preparation of key performance indicator (KPI) reporting for the team.
* Supporting administrative tasks as required.
* Assisting in carrying out internal audits and preparing for external audits.
* Providing cover and support in other areas of the team during periods of high volume or annual leave.
Requirements
* Experience working within a regulatory affairs role within medical devices/pharma distribution.
* Understanding of MDR Regulation 2017/745, ISO 9001, and GDP.
* Strong communication, interpersonal, and prioritizing skills.
* Experience with technology platforms used for query management.
* Keen attention to detail.
* Strives for continuous improvement.
* Hold a valid working permit.
* Full clean driving license.
Benefits
This role will be mainly based in our office where a flexible hybrid working model is also available. We offer a balance between face-to-face interactions and virtual working over the long term.
We Go Forward Together: We operate as a unified team, leveraging diverse specialties to make swift, collaborative decisions and embrace progress over perfection.
We Take Our Business Seriously: We prioritize compliance and risk management to ensure the best outcomes for our patients and partners, supported by our innovative portfolio and commitment to sustainability.
We Deliver Exceptional Results: We focus on quality, customer satisfaction, and commercial success to achieve outstanding results for our patients, customers, and business.
We are an equal opportunities employer.