Job Description

Job Purpose (Role Definition)

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Working within the Quality Assurance and Regulatory Affairs team, the Senior Regulatory Affairs Engineer assures regulatory requirements are met for new product introduction and design changes to established products. To proactively support the Company in achieving regulatory goals and objectives and in achieving and maintaining the necessary regulatory clearances. 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 UK, European and international country specific legislations

Main Duties and Responsibilities

Ensure compliance to global regulatory requirements and company policies. Preparation of documentation for the filing of regulatory submission to US FDA Maintain compliance with Regulations as set by the Medicines and Healthcare products Regulatory Agency (MHRA) Maintain compliance with EU Medical Device Regulation (MDR). Develop and maintain policies and procedures for maintaining data in EUDAMED system, and other international regulatory systems. Prepare submission packages for European Agencies and other International Authorities within required timelines. Plan, lead and support regulatory efforts for new product launches. Keep up to date with changes in regulatory legislations and guidelines. Liaise and negotiate with regulatory authorities. Contribute to regulatory intelligence to produce and maintain applicable standards and processes. Be the point of contact for Regulatory support across the business functions. Establish and maintain regulatory information systems such as technical documentation and routine reports. Drive the understanding of existing and/or new regulatory requirements/guidelines and standards as they relate to company products and procedures. Regulatory responsibility for the compliance lifecycle management for assigned products/projects. To perform regulatory review of business documentation e.g. marketing material, design changes, and determine their impact on regulatory submissions. Assist and support inspections and audits.

Management Responsibilities

None

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 on Class II Medical Devices. Direct interaction with Regulatory authorities. Experience working across export markets and dealing with international distributors Familiar with EU Medical Device Directive and Medical Device Regulation. Experience of Quality System concepts, practices and procedures (for example, ISO 13485, MDSAP, CFR820); Problem solving mindset; proactive and solutions orientated.


Desirable

Knowledge of ISO14971, BS EN 60601, IEC 62366 and IEC 62304; Experience with Project Management; Experienced interaction with regulatory agencies; Continuous improvement mindset;

Key Skills and Competencies

Able to work as part of a team and across multi-disciplinary teams on projects and represent the department when required. Maintain assertiveness and integrity under pressure. Ability to interpret, adapt and implement product regulations. Strong written and verbal communication skills. Computer skills (MS Office products). Qualitative and quantitative analytical skills. Clean driving record - ability to travel as required. Fluent English a must. * Effective time management