Raq Manager

**RAQ Manager**
**Location**: Coventry, CV3 2RQ
**Salary**: Competitive, DOE
**Contract**: Permanent

**Regulatory Affairs and Quality Manager required**
**About the Company**:
SFM is an innovative medical devices manufacturer of advanced wound care products, including combination products, from gelling fibres and fabrics.
SFM delivers innovative, cost effective and quality products and solutions for the advanced wound care industry helping to improve patient care and wellbeing.
**RAQ Manager**:
This role is responsible for the delivery of the company’s development regulatory roadmap. This will be achieved through leading the regulatory elements of SFM’s product development efforts and compliance programme as well as supporting SFM’s customers’ regulatoryrequirements 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
- of regulatory and compliance input into product development and regulatory projects, including coordination of RAQ function resources for development and 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 SFM 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 SFM 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 SFM 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 SFM to achieve high standards of excellence, sharing best practice.
- Deliver any other duties as required by the Director of RAQ or the business.
**RAQ 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.
**Beneficial Additional Skills / Experience / Abilities**:

- 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.
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