REGULATORY AFFAIRS MANAGER (Medical Devices)

Company manufacturing Medical Devices located in Granollers needs to incorporate:

REGULATORY AFFAIRS MANAGER

Depending directly on the General Manager.

FUNCTIONS / RESPONSABILITIES:

• 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 Licence 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.
• Interface with regulatory and accreditation agencies (Notified Bodies, Health Competent Authorities).
• Participate in Notified Body, customer and other regulatory body inspections.
• Gather information and records across all departments to obtain product compliance. And compilation of technical information for regulatory requirements.
• 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.
• Guarantee that regulatory requirements are met in regards to local and national laws and company standards in order to place and/or maintain products on the markets. Liberalization of lots for commercialization.
• Maintain current knowledge of the developments and changes to applicable laws, regulations and industry standards, and assisting in the dissemination of this information within the company and sector.
• Interface with Health and Safety Agency and overseeing HS programs to assure regulatory compliance and meeting HS performance objectives.
• Monitor environmental management system to support environmental compliance, industrial hygiene rules and waste disposal.
• Provide input to development teams to assure that regulatory requirements and standards are incorporated in the product development process.
• Review promotional material and labelling to ensure applicable regulatory requirements are met.

WE OFFER:

• Long-term employment project.
• Negotiable salary according to the candidate's worth.

• Bachelor's Degree in Health Sciences: Pharmacy, Biology, Biochemistry, Chemistry...
• Minimum 3 years' experience in Quality Assurance, Technical and Regulatory Affairs in Medical Devices.
• Good working knowledge of ISO 13485, Medical Devices regulations and registration of MD in foreign countries.
• Strong organizational and interpersonal skills.
• Advanced verbal and written English (C1).
• Analytical skills, attention to detail, and able to manage multiple projects with shifting priorities