Technical/regulatory Affairs Manager

hace 4 días

Barcelona, España Page Personnel España A tiempo completo

Maintain up-to-date and follow all Company Quality Assurance System ensuring alignment with regulatory requirements as per Quality Standard EN ISO 13485:2016, the Medical Device Directive 93/42/EEC and new Regulation (EU) 2017/745 requirements
- Manage the EC Certificates, the EN ISO 13485 Certificate and the Manufacturer License issued by NB 0318-AEMPS (Spanish Health Ministry)
- Report and manage of complaints, vigilance system, non-conformities, CAPAs, supplier evaluation, management review, internal audits, labelling, product compliance, KPIs, risk management, projects, pest control, documents and records control
- Provide technical customer support
- Responsible for the development and maintenance of product data sheets, technical files and registration dossiers
- Lead and manage Quality Control Laboratory and two laboratory technicians, maintaining laboratory workflow, developing performance standards (such as ISO 4074) for analytical testing, quality compliance, SOP's, calibrations, equipment maintenance and other lab support functions
- Manage regulatory affairs responsibilities: product registration to establish regulatory strategies, authoring and/or reviewing regulatory documents (technical files, submissions), monitoring status of registrations, providing support for currently-marketed products, including review and update of product/ manufacturing process changes, supplier changes, new and revised reports, and product labelling
- Reviewpromotional material andlabellingtoensureapplicableregulatoryrequirements are met

Company that manufactures medical devices|Experience with ISO 13485
- Training in Health Sciences (Pharmacy,Chemistry...)
- Experience working with ISO 13485
- Experience in a similar position (Technical Director, Regulatory Affairs...)
- High Level of English

National company that manufactures and packages medical devices
- Immediate incorporation
- Good salary conditions

Company that manufactures medical devices is looking for a Technical/Regulatory Affairs Manager - Medical Devices

Technical/Regulatory Affairs Manager - Medical Devices

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