Regulatory Affairs Manager

Salary: £78,000 per year

Regulatory Affairs Manager

A global company that has led the way in the development and manufacture of respiratory ventilation products for 65+ years. With a reputation for delivering excellent clinical outcomes and a genuine ethical approach to business this is a fantastic opportunity to join an organisation that offers both huge career development opportunities and a hugely rewarding career.. 

Access to Basingstoke required circa x3 per week.

Basic IRO £78,000 with Bonus and Package

Job Description

Management of the compliance of company and products to all relevant regulations and standards encompassing a range of different product types including Medical Devices and accessories. Taking responsibility for Importer & Distributor obligations under the EU MDR along with assisting in QA documentation development & QMS maintenance.

Regulatory Affairs -Key Responsibilities

• Managing compliance of devices manufactured by the company and those products subcontract manufactured for the company, especially in the context of Importer & Distributor activities as “Economic Operators” under the EU MDR
• Managing the verification role on behalf of company affiliates acting as Distributors, using company databases, enterprise resource planning (ERP) systems and liaising with manufacturers to ensure the correct data is available
• Managing liaison with local Distributors to ensure seamless operation of the verification process along the supply chain throughout the relevant geographic areas
• Ensuring general compliance with regulatory requirements & liaison with Competent Authorities as appropriate
• Management of local RA/QA team
• Advice, as appropriate, on regulatory and associated requirements

Quality Assurance

• Writing and updating local/corporate procedures through the Corporate change request/control process
• Assisting the QA Manager and siting in for them in their absence
• Managing roll-out and instruction of affiliates, warehousing and distributors on appropriate QMS procedures and documentation regarding, but not limited to, MDR obligations
• Managing responses to enquiries/complaints etc from customers, distributors, other members of staff, regulatory authorities, national authorities, customs and imports, and related organisations – according to company procedures
• Site audits (internal & external) to ISO and related standards; support CAPA resolution

Provide

Appropriate reporting to the International QARA Director as required.

Assistance with any other appropriate tasks deemed necessary by management

Key Qualifications

Undergraduate degree in a scientific discipline

Trained in requirements of ISO 13485, ISO 9001, GMP

Trained in requirements of the EU MDR

Trained UKCA marking

Trained in Swis MedDO requirements

Key Experience

5+ years’ experience in a Medical Device RA or QA management role

Methodical, accurate and consistent attention to details

Good knowledge of the EU Medical Device Regulations

Auditing experience (potentially as certified auditor) would be of benefit

Good Knowledge of Global Regulatory registration submissions and maintenance would be of benefit

Experience with ERP systems for product distribution would be an advantage

Experience working with Electronic Medical devices would be an advantage

Person Specification

• Communicate effectively to resolve issues
• Excellent written and spoken English
• Meticulous data review
• Self-learner
• Strong computer-based application skills
• Ability to communicate complex ideas logically and simply
• Ability to manage multiple projects
• Ability to manage direct reports/team
• Deadline driven – ability to pick up new concepts and regulations quickly
• Adaptable – work in a fast paced ever changing environment

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Progress Sales Recruitment is a specialist sales only medical recruitment consultancy dedicated to offering client and applicants alike the highest levels of service. With over 10 years experience in recruitment we specialise in the following areas of work – Nurse Advisers, Clinical Specialists, Theatre Sales Specialists, Sales Executives, Business Development Managers, Team Leaders, Sales Managers, Sales Directors and all other sales focused roles within the medical sector. Our core therapy areas include Vascular, Endoscopy, Urology, Neurology, ENT, Infection Control, Anaesthesia, Blood Products, Diathermy, Infusion, Orthopaedics, Surgical Instruments and all PCT, Primary, Secondary, Theatre and Rehabilitation products.