Part of a collaborative regulatory affairs team supporting both new and existing medical devices
Preparation of global regulatory submissions, including US 510(k) and EU technical documentation
Partner closely with project teams to shape regulatory strategies
Maintain a working knowledge of global regulations, standards, guidance documents, country-specific requirements
Provide support for internal and Regulatory agency audits
Direct engagement with regulatory authorities as required
Complete regulatory change assessments
Develop and maintain company Standard Operating Procedures (SOPs)
Review product labeling to ensure compliance with regulatory requirements

A bachelor’s degree or equivalent experience, ideally in a scientific or technical discipline
Working knowledge of global medical device regulations, standards and guidance
Hands on experience preparing or supporting regulatory submissions
Strong communication skills, including technical writing
Ability to work effectively with cross functional and international teams
A proactive, analytical and solution focused mindset

Regulatory Affairs Specialist

Key skills