Team Leader Regulatory Affairs & Compliance - Regenerative Solutions

Straumann

Basel, Switzerland

Job Purpose

As Team Leader Regulatory & Compliance - Regenerative Solutions, you will be part of a small but highly motivated and very international team, dedicated to our regenerative product portfolio. With your regulatory and compliance knowledge, you will support product developments and life cycle activities for the regenerative portfolio in order to expand the availability of the products worldwide.

Main Tasks and Responsibilities

Ensure that all products in scope are designed, manufactured and distributed in such a way that they are safe and effective for their intended use and meet applicable regulatory requirements, incl. change management;
Interact with authorities, Notified Bodies and other approving authorities and support during audits and inspections;
Guide and coach stakeholders in Regulatory and Compliance topics with particular focus on product safety and effectiveness/performance;
Supervise/support the process of establishing project-related RA strategies and follow up on execution during the projects;
Create/support and maintain Technical Files/Design Dossiers to complies with appropriate regulations;
Support the Regulatory Affairs teams in HQ and at subsidiaries/distributors in preparation of local submissions in line with agreed timelines and in compliance with relevant regulations;
Monitor and communicate new regulatory requirements and support in implementing these.

Profile

Education

Technical or scientific graduate degree (FH/Uni/ETH);
Fluent (written and spoken) in English, strong commend in technical writing;
Any additional language is an asset.

Experience

10 years professional experience in Regulatory Affairs and/or Quality Management;
Proven record of Regulatory Management level positions at various medical device companies and/or types of devices (risk classes);
Detailed knowledge about the standards and norms for Medical Devices such as ISO 13485, EU 2017/745, FDA and Health Canada requirements;
Experience with other jurisdictions (APAC; LATAM and DEMEA) would be beneficial;
Experience with Biomaterials and class lll products would be an asset.

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