Regulatory Affairs Specialist
3 weeks ago
Senior Regulatory Affairs Specialist
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 opportunityto 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 £50k with Bonus and Package
**Job Function**
The management of company and product compliance to all relevant aspects of the new UK MDR and UK CA marking and related standards. This will encompass the range of product types including medical devices and accessories. Responsibilities include:
- researching and dissemination of requirements relating to supply, distribution & regulatory registrations in the UK.
- the design, generation, review, implementation, and upkeep of the associated Quality Assurance documentation along with effective support during audits.
**Key Responsibilities -**
To provide:
- Regulatory compliance and registrations of devices manufactured by the company, especially in the context of UK MDR & CA marking requirements.
- Supporting activities to UK CA marking, including aspects such as updates to technical documentation, CA Declarations of Conformity, inputs to labelling & IFU changes,
products supplied for distribution by 3rd-party manufacturers, and the necessary procedural documents and Quality Agreements.
- Implementation of the means to fulfil "Economic Operator" obligations under the UK
MDR especially in the context of Importer & Distributor general & verification activities.
- Managing the verification role on behalf of client affiliates acting as Importers &
Distributors, using company databases, enterprise resource planning (ERP) systems and liaising with manufacturers to ensure the correct data is available
- Liaison with local Distributors to ensure seamless operation of the verification process along the supply chain throughout the relevant geographic areas
- Device registrations with the UKMHRA with appropriate data added via the MHRA portal.
- Liaison with Competent Authorities as required.
- Advice, as appropriate, on regulatory and associated requirements
- Assistance with QMS maintenance in support.
- Representation of the International RA Manager when required to ensure the QA/RA viewpoint is adequately considered.
- Any other appropriate tasks deemed necessary by management.
**Key Qualifications (ideal)**
- Undergraduate degree in a scientific discipline
- Trained in requirements of the EU MDR
- Trained in requirements of ISO 13485, ISO 9001; (GMP would be of benefit)
Ideally 5 years’ experience in a Medical Device RA role
- Methodical, accurate and consistent attention to details
- Knowledge of the EU & UK Medical Device Regulations
- Able to disseminate knowledge to affected parties
- Excellent knowledge of the requirements relating to the supply & distribution of medical devices in the EU, & UK
- Knowledge of Global Regulatory registration submissions and maintenance
- Experience with ERP systems for product distribution would be an advantage
- Experience working with Electronic Medical devices would be an advantage
**Key Skills -**
- Ability to communicate complex ideas logically and effectively
- Excellent written and spoken English
- Meticulous data review
- Pro-active self-starter & self-learner, able to work on own initiative
- Ability to manage multiple complex projects
- Deadline driven - ability to pickup new concepts and regulations quickly
- Adaptable - work in an ever-changing environment
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.
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