Regulatory Affairs Manager – Medical Device – Home Based

Apsida Life Science are currently partnered with a Global Leader in the implant system space.

The organisation are at the forefront of their industry offering cutting edge implant technology to patients. They have a wide ranging portfolio that is marketed globally with a large amount of revenue generated being pumped back into R&D.

They are looking to on board a Regulatory Affairs Manager to be home based with occasional travel to the office in Switzerland. The individual will be responsible for preparation and submission for registration/CE marking and renewals across Europe.

Responsibilities:

• Regulatory compliance and the maintenance of international product licenses, existing registrations/CE certifications and product technical documentation throughout the product life cycle.
• Preparing and defending pre-market, changes and renewal submissions to obtain approvals to commercially distribute products in international markets outside of the Americas including the development of sound regulatory strategy.
• Work closely with competent authorities and notified bodies.
• Assistance in audits by external bodies

Requirements:

• Degree in a Life Science related field.
• Over 3 year’s experience in Regulatory Affairs or Quality Assurance
• Previously dealt with product registrations in a medical device company for Class I, II & III products, experience with active implantable devices would be an asset
• Fluent in English
• Based in Switzerland or available to relocate from an EU country.

For further info get in touch!