Regulatory Affairs Manager SSU Endoscopes

Your Mission

• You are responsible for the regulatory support of our product line "Sterile single-use endoscopes" throughout the entire product lifecycle.
• You support and take over the coordination in the creation of technical documentation for assigned medical product groups.
• You identify global regulatory requirements for assigned medical product groups.
• You take over the development of testing and approval strategies for global distribution.
• Analysis and optimization of processes and procedures are also part of your tasks.
• You monitor compliance with regulatory requirements throughout the product lifecycle.
• You work closely with development teams and business partners from other departments.
• You ensure targeted training of development teams regarding regulatory requirements.

Your Talents

• Completed scientific/technical studies
• Several years of experience in the field of Regulatory/Quality Product Lifecycle for sterile medical products, preferably for sterile single-use endoscopes
• Knowledge of common sterilization procedures and regulatory requirements for the production of sterile medical products, preferably for sterile single-use endoscopes
• Familiarity with relevant international and regional standards, guidelines, and regulations for sterile medical products, preferably for sterile single-use endoscopes
• Expertise in medical-technical products (preferably endoscopy/imaging and sterile products) is desirable
• Confident presence in global project structures
• Communicative and analytical skills
• Independent and structured working style
• Very good English skills, Estonian language would be beneficial

Candidates are expected to submit a CV in English.

Your Benefits

• Interesting and challenging work
• Opportunity to contribute to the production of novel medical instrumentation
• Opportunity to work in an international and well-known company
• A supportive team and modern working-environment
• Sport opportunities (volleyball, yoga, walking and running series)
• Recognising birthdays and other personal important occasions
• Various team and joint events