Arbetsbeskrivning

About Linxens

Linxens is a global leader in micro-connectors, module packaging, antennas & inlays, and secure ID solutions, with over 40 years of innovation. Headquartered in Paris, France, we operate R&D centers and production sites across Germany, France, Sweden, China, India, Singapore and Thailand.

Our solutions serve industries such as telecommunications, finance, transportation, hospitality, e-government, healthcare, and the Internet of Things (IoT).

Our employees’ expertise and know-how allow us to continually reinvent ourselves and meet our customers’ evolving needs, helping them grow and innovate. Therefore, we invest in developing our employees’ skills and career growth.

Working for Linxens means investing in your future. Our growth is creating great opportunities!

Below is the job description for our open position as Head of Regulatory Affairs & Quality

Responsibilities

• Build, develop, and expand team of Healthcare RAQA leaders with local sites
• Establish, maintain, and continuously enhance regulatory and compliance frameworks aligned with vendor requirements, ISO 13485, QSR, and applicable regulatory standards.
• Oversee and strengthen compliance across key areas - Quality Management Systems (QMS), process validation, IT / software validation
• Conduct gap analyses between current practices and target regulatory compliance.
• In close collaboration with local leaders, define and execute project plans and corrective actions, maximizing synergies across sites and driving a harmonized, multi-site RAQA organization.
• Identify process, procedure, instruction, and form owners; ensure appropriate training, authorization, and accountability for remediation and continuous improvement initiatives.
• Coordinate execution by local leaders and process owners; provide regular reporting to Business Unit and Corporate Quality.
• Partner with legal to ensure healthcare-specific regulatory requirements are embedded in all binding customer and vendor agreements (e.g., SQAs, SSQA/MSA templates).
• In cooperation with Corporate Quality and IT, define user requirements (URS), oversee implementation and validation of EDM, ERP, and eQMS systems specific to the HLC Business Unit, regardless of location.
• Identify, train, and commission internal auditors in partnership with local leaders to internalize audit capabilities.
• Ensure appropriate RAQA staffing and resources are available to support, product development projects, design changes, non-conformances (NCs), change controls (CCs), and CAPAs.
• Develop and deploy best-in-class audit and inspection practices, including

Qualification

• 10 years of experience in Regulatory Affairs & Quality Assurance within the medical device industry
• Bachelor’s or Master’s degree in Mechanical Engineering, Manufacturing Systems, or a related discipline.
• Strong hands-on experience with ISO 13485, QSR, MDSAP, ideally as a vendor/manufacturer.
• Proven project management skills with the ability to operate effectively in complex, multi-site environments.
• Demonstrated ability to work transversally and globally, leading through influence rather than hierarchy.
• Fluent in Swedish and English.

Join Linxens to work in a multicultural environment, collaborating with leading tech innovators and making a global impact on technology.