Regulatory & Compliance Manager


Premium Job From Real Staffing

Recruiter

Real Staffing

Listed on

2nd October 2018

Location

London

Salary/Rate

£55000 - £65000

Type

Permanent

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Regulatory and Compliance Manager (Medical Devices)

Location: London

Our client is a fast growing medical technology company that uses advanced machine learning to develop and deliver intelligent tools/medical devices. They work with radiologists in their role in diagnosis, treatment, and patient outcome. They are looking for a Regulatory and Compliance Manager due to a fast period of growth.

Role

As Regulatory and Compliance Manager, you will be responsible for defining and planning the company's processes for regulatory submissions according to company goals and strategy. You will work closely with our management, operations, product and engineering teams in defining, developing, improving, and managing our company's quality management system (QMS) to ensure our processes are compliant with relevant industry standards and medical device requirements. You will also proactively seek out ways in which we can maximise our efficiency and effectiveness in developing high quality products, encouraging risk-based thinking across company activities and processes and a quality-focused culture.

Responsibilities

* Creating and maintaining regulatory documentation, preparing regulatory submissions (such as technical files), and managing the regulatory submission process (e.g. for CE marking)

* Defining requirements and managing the processes for preparing technical and regulatory documentation and submissions

* Ensuring our processes are compliant with relevant industry standards and medical device requirements (such as ISO 13485, EU Medical Device Directive/Regulation (MDD/MDR), EN/IEC 62304, ISO 14971, etc.)

* Ensuring related training is provided where needed to comply with relevant industry standards, medical devices requirements, and internal policies and procedures

* Supporting the development of quality products to help achieve company goals and ensure all lessons learned and appropriate changes are implemented (e.g. processes that support the lifecycle of medical devices such as design control, design change, design verification & validation, integration and deployment testing, post-market surveillance, and handling customer complaints)

* Core quality assurance and compliance activities such as conducting internal audits, preparing management reviews, CAPA management etc., as well as strict and consistent risk management activities

* Managing notified body audits or any competent authority or regulatory body inspections

* Leading on the development of our QMS for a scaling team and for new territories as the company grows

Requirements

* Experience working in healthcare and/or with software medical devices

* Understanding and experience with ISO 13485, MDD/MDR, EN/IEC 62304, ISO 14971, and similar standards and regulations

* Awareness of changing worldwide regulations and standards that are relevant to medical devices such as the MDR

* Experience writing and preparing submissions for CE marking

* Writing easy-to-follow policies and procedures

* Strong MS Office / Google apps skills, particularly excel / sheets

* Process driven, organised and structured in your thought and execution

* Highly analytical, data driven, numerically literate

* Meticulous attention to detail

* Comfortable working in very agile and fast-paced environments with a fast growing team

* Can do attitude - no challenge is too great, no task is too small, able to work under pressure

* You care - about the people your work with, the company's vision and your role in supporting that vision

* A bonus:

* Experience with FDA CFR Title 21 Part 820 and FDA regulatory submissions

* Experience with MDSAP

* Experience with DCB 0129 and DCB 0160

* Experience with ISO 27001, NHS Digital's Data Security and Protection Toolkit, Cyber Essentials or similar information security standards/guidance

* Project management experience

Benefits

* The opportunity to work alongside an inspiring team at the cutting edge of research, creating products to help the early detection of cancer

* Competitive salary, dependent on experience

* % Equity (share options) in the company

To find out more about Real please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales

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