Senior Raq Executive

3 days ago


Binley Industrial Estate, United Kingdom SFM Full time

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

**Senior Regulatory Affairs and Quality Executive required**

**About the Company**:
SFM is an innovative medical devices manufacturer of advanced wound care products, including combination products, from gelling fibres & fabrics.
SFM delivers innovative, cost effective and quality products and solutions for the advanced wound care industry helping to improve patient care and wellbeing.
**Senior RAQ Executive**:
This role is responsible for the delivery of the company’s product submissions and registrations roadmap. This will be achieved through leading SFM’s product submissions for global territories, supporting SFM’s customers’ regulatory requirements and projects.
**Duties include**:

- Compile and update internal submission files/dossiers for registrations, advice to concerned development departments regarding the regulatory requirements for regulatory, compliance and registration requirements to ensure the registration of the productsworldwide.
- Coordinate the design change control procedures (collection of regulatory assessments worldwide) and their international implementation.
- Support the delivery of the SFM quality and regulatory training and awareness program to provide the company with enhanced knowledge of regulatory requirements.
- Prepare and update product labelling text according to company core data and approved guidelines, and responsible for the management of translation.
- As a Subject Matter Expert (SME) 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 supporting the maintenance ofthe business’ regulatory database.
- Support the delivery of the vigilance programme for SFM and provide relevant support for its customers.
- Support the delivery of the regulatory requirements of the SFM 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.
**Senior RAQ Executive - 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
- Experience of registration/submissions in Brazil, Russia, India, China and Spain highly desirable
- Ability to gather, analyse and interpret regulatory information and changes in the regulatory landscape
- Pragmatic team member and flexibility to work within the dynamics of a cross-functional team
**Beneficial Additional Skills / Experience / Abilities**:

- 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
- Strong communication skills, goal and solution orientation, flexibility and assertiveness
- 3-5 years of experience in international regulatory affairs for medical devices or pharmaceuticals with approbation
- Experience of developing regulatory strategies for new product registrations
- Demonstrable experience of gaining approbation for products globally
**Important Information**:
For Privacy Notice for Job Applicants please visit our website
**No agencies please



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