Regulatory Affairs Specialist - Medical Devices

• Experience with ISO13485, FDA, MDR, CE|High Level of English

Important company who develops and markets medical post-processing software products

The regulatory affairs specialist will join a team of highly skilled specialists in Regulatory and Quality affairs. The team is responsible for the QMS system maintenance and regulatory submissions of the products.

Main responsibilities

• Ensure that the company's products comply with the regulations of the countries we are marketing our products


• Keep up to date with national and international legislation, guidelines, and customer practices


• Evaluate applicable laws and regulations to determine impact on company activities


• Ensure accurate timely submissions to regulatory agencies


• Assist with the preparation and submissions of regulatory dossiers


• Prepare submissions of licence variations and renewals


• Proactively collaborate with the Quality Assurance Team to meet product regulatory requirements, including data generation and completion of required dossiers for product approval


• Train company staff in matters related to regulatory affairs

• Offices in Barcelona city


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  Careers oppurtinities and professional development


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  Two days of teleworking a week


• Leading technology company in our market

• Minimum of a Bachelor's Degree in a scientific field such as Biochemistry, Chemistry, Pharmacy or Molecular Biology or engineering, computer science, bioengineering


• 2 years' experience in working in a quality department ISO 13485


• EU and/or FDA clearance procedure experience will be highly valued


• Excellent written and verbal communication skills, with the ability to effectively communicate regulatory information in English