Regulatory Affairs
2 weeks ago
Herald Way, Binley Industrial Estate, Coventry CV3 2RQ, UK
SFM Ltd are recruiting for a Regulatory Affairs and Quality Manager to join the team in Coventry, CV3 2RQ
Regulatory Affairs and Quality Manager
Contract: Full time, Permanent
Regulatory Affairs and Quality Manager – Benefits:
Contributory pension scheme
Life cover
Cash Back Medical Scheme
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.
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.
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.
Networking abilities with internal and external stakeholders (competent authorities and registration bodies).
Comprehensive knowledge of processes and regulations in medical device and drug development; Medical device or pharmaceutical product manufacturer experience.
Experience of developing regulatory strategies for new product development and design changes.
For Privacy Notice for Job Applicants please visit our website
Registered Office: 36B Speirs Wharf, Port Dundas, Glasgow, G4 9TG
-
Regulatory Affairs Specialist
Found in: Appcast UK C C2 - 2 weeks ago
Coventry, United Kingdom VRS Regulatory Full timeAn opportunity for a regulatory affairs professional to join a chemical products manufacturing business. Key elements of the role include:Regulatory research and analysisMaintenance of key chemical regulatory documentsCompilation of regulatory dossiers to support product approval globallyAuthoring and maintenance of safety data sheets.This is a challenging...
-
Regulatory Affairs Specialist
Found in: Jooble UK C2 - 2 weeks ago
Coventry, United Kingdom VRS Regulatory Full timeAn opportunity for a regulatory affairs professional to join a chemical products manufacturing business. Key elements of the role include: Regulatory research and analysis Maintenance of key chemical regulatory documents Compilation of regulatory dossiers to support product approval globally Authoring and maintenance of safety data sheets. This is a...
-
Regulatory Affairs Specialist
Found in: Appcast UK C2 - 2 weeks ago
Coventry, United Kingdom VRS Regulatory Full timeAn opportunity for a regulatory affairs professional to join a chemical products manufacturing business. Key elements of the role include:Regulatory research and analysisMaintenance of key chemical regulatory documentsCompilation of regulatory dossiers to support product approval globallyAuthoring and maintenance of safety data sheets.This is a challenging...
-
Regulatory Affairs Specialist
Found in: Whatjobs ES C2 - 6 days ago
Coventry, United Kingdom VRS Regulatory Full timeAn opportunity for a regulatory affairs professional to join a chemical products manufacturing business. Key elements of the role include: Regulatory research and analysis Maintenance of key chemical regulatory documents Compilation of regulatory dossiers to support product approval globally Authoring and maintenance of safety data sheets. This is a...
-
Regulatory Affairs Specialist
Found in: Appcast Linkedin GBL C2 - 2 weeks ago
Coventry, United Kingdom VRS Regulatory Full timeAn opportunity for a regulatory affairs professional to join a chemical products manufacturing business. Key elements of the role include:Regulatory research and analysisMaintenance of key chemical regulatory documentsCompilation of regulatory dossiers to support product approval globallyAuthoring and maintenance of safety data sheets.This is a challenging...
-
Regulatory Affairs Specialist
2 weeks ago
Coventry, United Kingdom VRS Regulatory Full timeAn opportunity for a regulatory affairs professional to join a chemical products manufacturing business. Key elements of the role include: Regulatory research and analysis Maintenance of key chemical regulatory documents Compilation of regulatory dossiers to support product approval globally Authoring and maintenance of safety data sheets. This is a...
-
Regulatory Affairs Specialist
Found in: Talent UK 2A C2 - 2 weeks ago
Coventry, United Kingdom VRS Regulatory Full timeAn opportunity for a regulatory affairs professional to join a chemical products manufacturing business. Key elements of the role include:Regulatory research and analysisMaintenance of key chemical regulatory documentsCompilation of regulatory dossiers to support product approval globallyAuthoring and maintenance of safety data sheets.This is a challenging...
-
Regulatory Affairs Specialist
1 week ago
Coventry, United Kingdom VRS-UK Full timeWe are looking for a regulatory affairs professional to join a chemical products manufacturing business. Key elements of the role include regulatory research and analysis, maintenance of key chemical regulatory documents, compilation of regulatory dossiers to support product approval globally and, authoring and maintenance of safety data sheets. This is a...
-
Regulatory Affairs Specialist
2 weeks ago
Coventry, United Kingdom VRS-UK Full timeWe are looking for a regulatory affairs professional to join a chemical products manufacturing business. Key elements of the role include regulatory research and analysis, maintenance of key chemical regulatory documents, compilation of regulatory dossiers to support product approval globally and, authoring and maintenance of safety data sheets. This is a...
-
Regulatory Affairs Specialist
Found in: Whatjobs ES C2 - 6 days ago
Coventry, United Kingdom VRS-UK Full timeWe are looking for a regulatory affairs professional to join a chemical products manufacturing business. Key elements of the role include regulatory research and analysis, maintenance of key chemical regulatory documents, compilation of regulatory dossiers to support product approval globally and, authoring and maintenance of safety data sheets.This is a...
-
Regulatory Affairs Specialist
2 weeks ago
Coventry, United Kingdom VRS-UK Full timeWe are looking for a regulatory affairs professional to join a chemical products manufacturing business. Key elements of the role include regulatory research and analysis, maintenance of key chemical regulatory documents, compilation of regulatory dossiers to support product approval globally and, authoring and maintenance of safety data sheets. This is a...
-
Regulatory Affairs and Quality Manager
1 week ago
Coventry, United Kingdom SFM Full timeRegulatory Affairs and Quality ManagerLocation: Coventry, CV3 2RQSalary: Competitive, DOEContract: Full time, PermanentRegulatory Affairs and Quality Manager - Benefits:Competitive salaryContributory pension schemeLife coverIncapacity benefitsCash Back Medical SchemeAbout the Company:We are an innovative medical devices manufacturer of advanced wound care...
-
Regulatory Affairs and Quality Manager
4 days ago
Coventry, West Midlands, United Kingdom SFM Full timeRegulatory Affairs and Quality ManagerLocation: Coventry, CV3 2RQBelow, you will find a complete breakdown of everything required of potential candidates, as well as how to apply Good luck.Salary: Competitive, DOEContract: Full time, PermanentRegulatory Affairs and Quality Manager - Benefits:Competitive salaryContributory pension schemeLife coverIncapacity...
-
Regulatory Affairs
Found in: Jooble UK C2 - 2 weeks ago
Coventry, United Kingdom SFM Full timeRegulatory Affairs and Quality Manager Coventry, CV3 2RQ Salary: Competitive, DOE Contract: Full time, Permanent Regulatory Affairs and Quality Manager - Benefits: Competitive salary Contributory pension scheme Life cover Cash Back Medical Scheme We are an innovative medical devices manufacturer of advanced wound care products,...
-
Compliance Administrator
Found in: Talent UK C2 - 1 week ago
Coventry, United Kingdom Pertemps Bond Full timeCompliance AdministratorMy client is a leading estate agency committed to providing exceptional real estate services to our clients. They specialize in lettings and strive to uphold the highest standards of professionalism, integrity, and compliance in all aspects of their operations.We are seeking a diligent and detail-oriented Compliance Administrator to...
