Group Regulatory Affairs Specialist Class II (m/f/d)

As a Group Regulatory Affairs Specialist Class II, you will research and determine regulatory requirements, monitor the regulatory environment, and provide creative and innovative internal advice to ensure product compliance. Your responsibilities will include regulatory frameworks and strategy, product development and registration, postapproval/postmarket, business acumen, and scientific and health concepts.

Requirements

• Master's degree in science
• In-depth knowledge of US and Canada regulations, standards, and guidance documents for medical devices
• Knowledge of medical device regulations in Central America, South America (Brazil) is an asset
• Knowledge of quality management systems and medical device standards such as ISO 13485, ISO 14971,...
• Certifications in regulatory affairs like RAC are an asset
• Fluent in English and any other language is considered an asset
• Minimum of 3 years experience in Regulatory Affairs for medical devices
• Experience in 510k submission
• Experience or interest in regulatory affairs for Software as Medical Device (SAMD)
• Experience in working with cross-functional teams and building strong relationships across departments

Benefits

• Holiday and Christmas bonuses
• 30 days of holiday
• Company pension scheme
• Corporate benefits and discounts