Regulatory Affairs and Quality Manager

Regulatory Affairs and Quality Manager

Location: Coventry, CV3 2RQ
Salary: Competitive, DOE
Contract: Full time, Permanent

Regulatory Affairs and Quality Manager - Benefits:

• Competitive salary
• Contributory pension scheme
• Life cover
• Incapacity benefits
• Cash Back Medical Scheme

About the Company:

We are an innovative medical devices manufacturer of advanced wound care products, including combination products, from gelling fibres and fabrics. We deliver innovative, cost effective and quality products and solutions for the advanced wound care industry helping to improve patient care and wellbeing.

Regulatory Affairs and Quality Manager - The Role

This role is responsible for the delivery of the company’s development regulatory roadmap. This will be achieved through leading the regulatory elements of the company’s product development efforts and compliance programme as well as supporting its customers’ regulatory requirements and

projects.

Duties Include:

• Lead the provision and development of regulatory strategies, participate in project teams and act as the lead person with regards to regulatory requirements for product development and design changes.
• Deliver regulatory and compliance inputs into product development and regulatory projects, including coordination of RAQ function resources for development and design change control projects.
• Undertake the role of the Regulatory Project Lead (RPL) in business projects supporting the delivery of relevant outputs from the project and managing the regulatory project, with clear leadership.
• Support the development of global regulatory strategies for the company and its customers’ development for new and modified products for primary markets USA, EU, and UK.
• Lead the delivery of the vigilance and post market surveillance programme (PMS) for the company and provide relevant support for its customers.
• Maintain compliance and improvement to the business compliance and regulatory systems including the risk management programmes.
• Assess the impact of global regulatory and standard changes on the products and Quality Management System (QMS) of the business and its customers, acting as the Subject Matter Expert (SME) and maintaining the business’ regulatory database.
• Lead the delivery of the company’s quality and regulatory training and awareness program to provide the company with enhanced knowledge of regulatory requirements.
• Support the management of communication with Regulatory Authorities and Notified Bodies to address regulatory and compliance issues.
• Support the delivery of the regulatory requirements of the QMS including managing CAPAs, document change controls, audits.
• Contribute to create and maintain a proactive leadership style and compliance culture throughout the company to achieve high standards of excellence, sharing best practice.

Regulatory Affairs and Quality Manager - Key Skills / Abilities:

• Regulatory, science or engineering degree or equivalent.
• Knowledge of the Medical Device Directives Regulation EU 2017/745/EEC, 21 CFR 820, UKCA
• Ability to gather, analyse and interpret regulatory information and changes in the regulatory landscape, taking ownership for delivery.
• Pragmatic team member and flexibility to work within the dynamics of a cross-functional team.
• Great communication skills.

Desirable Additional Experience:

• Experience of managing people in a similar role, with the ability to lead, influence, and motivate a team.
• Networking abilities with internal and external stakeholders (competent authorities and registration bodies).
• Strategic and analytical thinking.
• Highly Structured way of working.
• Comprehensive knowledge of processes and regulations in medical device and drug development; combination product (device-device), drug Masterfile compilation experience is highly desired.
• Strong communication skills, goal- and solution orientation, flexibility, and assertiveness.
• Medical device or pharmaceutical product manufacturer experience.
• Experience of developing regulatory strategies for new product development and design changes.
• Demonstrable experience of technical files, design dossier and drug master file creation.

If you have the skills and experience, we require for this role and are looking for a new challenge, please get in touch by clicking on Apply today and forward your CV to us, explaining why you are a great fit for this role.

Important Information:

Due to the number of applications, we receive, we will only contact those candidates that we want to take forward to interview; if you do not hear from us within 4 weeks, please assume that your application has been unsuccessful on this occasion, and we wish you all the best.

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