Regulatory Compliance Engineer

QTC are partnered with a global speciality medical device company focused on creating and manufacturing high-quality class II devices for opthalmology disorders. Products are designed and produced in-house and distributed worldwide via a network of third-party suppliers. The company consists of a skilled team across Regulatory and Quality functions, working extensively across EU, US, and Asian markets.

Our client are searching for a Regulatory Compliance Engineer to join their team on a permanent basis. The role will focus primarily on identifying, evaluating, and ensuring compliance across relevant regulatory laws internationally. Activities will include: Remaining aware of new regulations and standards for MDR. Providing analysis and updates for revisions based on current recommendations. Submitting adverse and corrective action reports. Keeping EUDAMED registrations up to date across all sites. Author and coordinate regulatory product clearance submissions. Assist in submitting registration applications and acting as the interface with regulatory agencies.

Requirements:

• Technical degree in science or engineering
• Excellent command of the English language
• Knowledge of Medical Device related regulations MDD and MDR
• Experience in product registrations for EU and Asia
• Experience with SOP, validation, and technical writing desirable

Offer:

• Dynamic role in a leading international organisation in their field
• Competitive basic salary with additional bonuses
• Flexible work pattern
• 30 holiday days