Regulatory Affairs Specialist / Senior Specialist

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Regulatory Affairs Specialist / Senior Specialist

SHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto injectors or pen injectors to effectively deliver their drugs. Headquartered in Switzerland since late 2018, with sites in Sweden, Taiwan, and the United States.

Job Overview

A Regulatory Affairs Specialist / Senior Specialist is capable of independently perform below task & participate/execute inter-departmental communication and relevant compliance activities.

Main Responsibilities

• Compile, review and submit regulatory applications, and support customers’ products registration.

• Provide regulatory guidance to project team, review QMS and product documentation. Participate in design review meetings to ensure all documents needed for filings are in compliance with relevant regulations/standards/guidance.

• Coordinate the implementation of updated regulations and standards.

• Collaborate with SHL Global RA Team to develop and implement strategies for the regulatory submission and improvement.

• Collaborate with other departments to ensure quality and regulatory activities are performed in accordance with Quality policy.

• Other regulatory tasks.

Skills and Qualification

• Bachelor or master’s degree in medicine and health, science, electrical and electronic engineering, or relevant field.

• Two years plus related work experience. Experience in sterile medical device, electrical medical device or pharmaceutical industry is preferred.

• Fluent in written and verbal English. Good interpersonal and communication skills.

We Offer

• An exciting opportunity in a fast-growing international medical device company

• A modern working environment, with multicultural and dynamic teams

• Flexible working hours and a hybrid remote work policy