Regulatory Affairs Team Lead

vor 2 Wochen

Basel, Basel-Stadt, Schweiz Straumann Group Vollzeit
Job Title: Regulatory Affairs Team Lead

About the Role:

We are seeking a highly skilled Regulatory Affairs Team Lead to join our team at Straumann Group. The successful candidate will be responsible for ensuring that all products in scope are designed, manufactured, and distributed in accordance with applicable regulatory requirements.

Main Responsibilities:

* Ensure that all products in scope are safe and effective for their intended use and meet applicable regulatory requirements
* Interact with authorities, Notified Bodies, and other approving authorities to 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 comply 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

Requirements:

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

Working Conditions:

* Full-time position
* 0-20% travel

What We Offer:

* Competitive salary and benefits package
* Opportunity to work with a leading company in the medical device industry
* Collaborative and dynamic work environment

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