Regulatory Affairs Specialist. Zürich. Suiza

Job Description:

Contribute to execution of distributed product development, change, compliance and lifecycle management activity projects/activities for market access to EU, US & CA to ensure all RA related strategies, elements & requirements implemented and collaborate with other Nobel RA teams for smooth registration in applicable markets.

Create, review and maintain product technical files.

Support provision of regulatory guidance for Nobel Biocare IFU and labeling.

Contribution to review and approval of product related labeling and marketing material and associated claims.

Support internal and external audits with audit preparation and in audit back office.

Support the creation and maintenance of regulatory procedures and templates.

Support monitoring of guidelines, regulations, changes in the marketplace and regulatory positions for the assigned markets including creation of gap analyses.

Maintain UDI processes (such as GUDID) and contribute to implement additional country UDI processes (such as EUDAMED). Further monitor changed UDI legislations and medical device database requirements for assigned region.

Ensure timely and accurate UDI submissions for new launch projects.

Provide regulatory input in UDI and RA data governance projects, including testing of IT solutions under guidance.

Job Requirements:

A minimum of a Bachelor’s degree from accredited college or university is required. A Master’s degree or PhD is of advantage. A degree focused in technology or science is preferred.

Experience in medical device or similar regulated working environment.

Knowledge of EU, US and CA medical device regulations. Further markets are an advantage.

Knowledge of requirements for technical documentation of medical devices or similar devices.

Knowledge of medical device quality management systems 21 CFR Part 820 and ISO 13485.

Fluency in English a must, German or other languages are an advantage.

Knowledge of SAP including systems & understanding data handling.

Knowledge in Office based programs, especially Excel.

Minimum 2 years' experience in regulatory affairs within medical device industry.