Regulatory Affairs Engineer

Regulatory Affairs Engineer

Job Purpose

Working within the Quality Assurance and Regulatory Affairs team, the Regulatory Affairs Engineer assures regulatory requirements are met for new product introduction and design changes to established products.

Reporting into the Head of Quality Assurance and Regulatory Affairs, s/he assures the design validation protocols contain the regulatory supporting evidence that the product meets or continues to meet intended use, user needs and labelling claims. Working closely with the Research and Development Group, s/he will also ensure the type testing certification such as electrical compatibility and compliance to product specific directives are in place. This assures the integrity of the design history file and technical file as a precursor to country specific registration(s).

This position provides and contributes to the delivery of Regulatory deliverables from internal Research and Development projects, contributes to providing Regulatory solutions to business requirements and changes to the regulatory landscape. This position provides operational Regulatory input and guidance to cross-functional teams, ensuring compliance to ISO 13485, FDA standards (and others based on business growth).

Main Duties and Responsibilities

• Assure integrity of the design history file and technical file prior to regulatory filings.
• Draft reports to regulatory agencies.
• Regulatory Responsibility for the compliance lifecycle management for products/projects assigned to him/her.
• Working closely with the Research and Development Group assessing regulatory implication of design changes.

Experience and Qualifications Required
Mandatory

• Degree in sciences, life sciences, engineering or quality management or equivalent education gained through work experiences;
• 3 years regulatory experience gained within the medical device, health or in vitro diagnostic sector;
• Experience of ISO 13485;
• Knowledge of ISO14971, BS EN 60601, IEC 62366 and IEC 62304;
• Organised in terms of prioritising workload and regulatory filings;
• Knowledge of risk management and design validation approaches. Understanding of type testing relating to software medical devices, electrical safety and other directives applicable to software medical devices.

Desirable

• 3-5 years in Medical Device related industry or in vitro diagnostic sector;
• Experience with regulatory agencies (such as FDA, MHRA);
• Experience with Project Management;
• Experienced interaction with regulatory agencies;
• Good awareness of FDA 21 CFR part 820 Quality System Regulation.

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