Senior Regulatory Affairs Executive
Location: Coventry, West Midlands
Salary: Competitive, DOE
Contract: Permanent, Full Time
About the Company:
SFM is an innovative Coventry-based B2B supplier of gelling fibres & fabrics for the advanced wound care industry. We offer a range of wound care technologies and all our products are manufactured in ISO certified clean rooms in line with the highest standards of care.
SFM’s aim is to successfully deliver innovative, cost effective and quality products and solutions into the advanced wound care industry with an ultimate aim of improving patient care and wellbeing.
Currently an exciting opportunity has arisen for a motivated and dynamic Senior Regulatory Affairs Executive to join and support RAQ team.
Senior Regulatory Affairs Executive – duties to include:
• Undertake the role of the 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 submissions for new and modified products
• Support the delivery of the vigilance programme for the company and provide relevant support for its customers
• Support the delivery of the regulatory requirements of the company’s QMS including managing CAPAs, document change controls, process audits
• Maintain compliance and improvement to the business compliance and quality systems including the risk management programmes
• Support the management of communication with Regulatory Authorities, and Notified Bodies to address RA questions and submission issues
• Support the management of the company’s training and awareness program to provide the company with enhanced knowledge of regulatory requirements
• Assess the impact of global regulatory and standard changes on the products and Quality Management Systems of the company and that of its customers
• Contribute to create and maintain a proactive leadership style and quality culture throughout the company to achieve the standards of excellence as set out in the company’s quality policy, and share best practice where possible.
Senior Regulatory Affairs Executive – Key skills / abilities:
• Regulatory, science or engineering degree or equivalent
• Knowledge of the Medical Device Directives 93/42/EEC, 21 CFR 820, Regulation EU 2017/745/EEC
• Ability to gather, analyse and interpret regulatory information and changes in the regulatory landscape
• Understanding of device classification MDR for Europe, for the USA
• Pragmatic team member and flexibility to work within the dynamics of a cross-functional team
• Awareness and appreciation of the need to influence in a business
• Good communication skills
• Significant experience within regulatory Affairs in a Medical Device environment
• Able to demonstrate a broad understanding of medical devices and regulatory affairs
• Able to get on with and influence people both internally and externally to achieve objectives.
• Able to work with minimum supervision and as a part of a team
• Strong communication skills, flexible attitude and capable of working to tight deadlines under pressure.
• Combination product (drug-device) experience desirable
• Medical device manufacturer experience
• Experience of developing regulatory strategies for new product development
• Demonstrable experience of technical files and design dossier compilation
• Competitive salary
• Contributory pension scheme
• Life cover
• Incapacity benefits
• Cash Back Medical Scheme
• Flexible working hours
If you have the skills and experience we require for this role and are looking for a new challenge please email your CV to us with a relevant cover letter, explaining why you are a good fit for this role
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.
No agencies please.
Employment Type Permanent
Advertiser Type Agency