Compliance Engineer Needed in Spain

Skills Provision is searching for a Compliance Engineer to work for a manufacturing company that specialises in the production of medical devices.

The employing company is looking for an engineer to be responsible for the compliance of all devices used in domestic and international markets.

Location: Barcelona, Spain

Position: 2-year initial contract

Salary & Benefits

• €53,000 pa
• Benefits package available

The Role

• Identify, analyse, and interpret applicable global regulatory requirements for all devices.
• Work with design teams from conception through product release and throughout product lifecycle.
• Play a leading role in ensuring compliance of all devices
• Interface with relevant regulatory and test agencies
• Ensure adherence to labelling requirements as dictated by local and global regulatory agencies.
• Participate in engineering change process to ensure continued regulatory compliance
• Ensure continued compliance of design changes through product lifecycle
• Provide audit support
• Participate on project teams for product risk management — identify hazards, mitigation measures, and residual risks. Perform subsequent audit of risk mitigations

Requirements

• Bachelor’s degree in Engineering or closely related technical field.
• Work experience in engineering, regulatory affairs and/or and quality systems in the medical device industry or other similar regulated industry — 10 years.
• Experience in training in groups and in public speaking.
• Hold supporting professional qualifications.
• Multi-lingual would be advantageous.
• Strong IT skills.
• Able to produce professional reports.
• Dedicated outlook and a team player.

Skills Provision is an ethical international recruitment agency, as such our adverts do not discriminate with regards to age, race, gender, colour, creed, religion, sexual orientation, disability and nationality.