Job Description
Job Description
Are you up for the challenge of bringing disruptive new technologies to the market for patients with chronic medical conditions? We are rapidly expanding and are looking for an experienced Quality & Regulatory Affairs Manager with experience of managing Class I, II, medical devices.
About Job:
As Regulatory Affairs Specialist you will be a key contributor to the success of the Quality Assurance and Regulatory Affairs (QARA) within the company, helping to ensure compliance to all applicable regulations, standards, and guidance by maintaining regulatory documentation, managing assigned processes, and representing Regulatory Affairs in key business projects. You will provide regulatory guidance and expertise to internal stakeholders, ensuring compliance of records, documents, and products at all times.
The QARA Manager role will require the post holder to proactively collaborate with colleagues from across the business.
How to Apply: To apply please send your covering letter to explain your motivation to apply along with your CV to careers@ipl.uk.com We will respond via email to your application to let you know if we would like to organise an initial interview or on this occasion have decided to decline your interest in this role.
Independence Products Ltd is an equal opportunity employer and we believe in and promote diversity and inclusion as key values across our business.
Company Description
Independence Products Ltd is an established UK supplier of medical devices designed to improve the quality of life of patients with chronic medical conditions. Independence Products was established in 2006 and now has over 45 employees based across the United Kingdom who are all passionate about providing high-quality products that meet the individual needs of our customers.
The Company’s initial focus was on a range of products designed to overcome common problems experienced by patients living with a stoma. Over recent years the focus has been on a commitment to helping dialysis patients to shower safely with the introduction of a range of specialist prescription products for patients receiving dialysis.
Main Duties & Responsibilities
• Implement regulatory strategies in New Product Development projects, from inception through to the Post-Market Surveillance phase, ensuring compliance to requirements throughout to support product launch.
• Monitor and review regulatory and standard changes, highlighting any impact on the business.
• Prepare and update Technical Files to MDD/MDR requirements and associated documents to ensure regulatory compliance for IPL medical devices are maintained.
• Provide business-wide support, ensuring regulatory compliance with requirements applicable to Unique Device Identifiers, technical standards and design processes, including Design History Files.
• Assess proposed change requests, highlighting regulatory implications, approve/reject where appropriate and maintain accurate records of actions implemented.
• Create strategies for regulatory compliance for markets assigned.
• Prepare and maintain regulatory submissions.
• Liaise with regulatory authorities, notified bodies and other external stakeholders as directed.
• Create and maintain technical files.
• Create and maintain templates and other documentation to support compliance with global requirements.
• Maintain device registration information in global systems.
• Continuously develop the QMS, including the implementation of systems supporting the QMS in compliance with applicable regulations.
• Act as the Management Representative for QA
• Support audits, ISO certification audit & QMS Management Review process
• Manage product complaint/quality investigations
• Train staff on quality procedures
• Maintain and review risk management files and Post-Market Surveillance files.
• Support Post-Market Surveillance & Vigilance tasks.
• Support sales and commercial activities, particularly with enquiries from customers and market authorities, concerning regulatory issues.
• Review and approve designs for packaging, labelling, instructions for use, marketing materials and technical documentation for compliance with relevant regulations and standards.
• Create and maintain procedures to ensure regulatory compliance across the business.
• Support the Head of department in reviewing and maintaining clinical evaluation reports.
• Support closure of general regulatory compliance issues as directed.
• Develop training materials for the wider business as directed.
• Support QARA during Notified Body audits, as directed by the Head of department.
• Lead assigned projects.
About You
The ideal candidate for this position will have the following experience, skills, and attributes. Please note that these competencies are not ranked in order of priority. The following criteria will be used in selecting a candidate:
• Educated to bachelor’s degree level (or equivalent). An advanced degree and/or Regulatory Affairs Certification (RAC) is preferred.
• Knowledge of ISO 13485 and Medical Device Directive/ Medical Devices Regulations
• Experience of product design and development procedures
• Experience of project quality management
• ISO13485:2016 auditor qualified
• Minimum of at least 2-3 years of experience in medical device Regulatory Affairs is required.
• Understanding of the regulatory framework for medical devices.
• Understanding of the Quality System Regulations ISO 13485:2016, recalls and correction and labelling requirements required. International experience is desirable.
• Demonstrable experience with Class I, II, medical devices.
• Experience working with EU 2017/745 MDR requirements.
• Current specialist knowledge of medical device regulatory requirements in the EU and UK.
• Knowledge of EN ISO 14971:2019 Risk Management and EN ISO 13485:2016
• Experience of working within a Quality Management System
In addition, you are a self-starter with the ability to work independently, self-managing your time efficiently and have effective problem solving skills. Strong interpersonal and collaborative skills are essential, they will enable you to execute both reactively and proactively and in a timely manner. You will be used to conducting thorough research of regulatory requirements and related issues to identify potential solutions and available options. Ability to plan, manage and execute project-based tasks often with tight deadlines Strong analytical skills with good judgment making capabilities. Demonstrated organisational skills. Strong oral and written communication skills. Proficiency with Microsoft Office (Excel, Word, PowerPoint), Adobe Acrobat etc.
Our transformation will change your career, for good. You'll be pushed to think bigger and aim for excellence. Your ideas will be heard, and you'll be supported to bring them to life. There'll be challenges. But stretch yourself and embrace the opportunities, and you could make your biggest impact yet!