5 days ago

Regulatory Affairs & Compliance Manager Projects (m/f)

Institut Straumann AG

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Join us and become part of our Regulatory Affairs & Compliance Team at our Headquarter in Basel. We are looking for you as Regulatory Affairs & Compliance Manager.

In this role you are responsible for the overall registration strategies, coordination, implementation, execution control and completion of product registration, assuring compliance with regulatory requirements.

Regulatory Affairs & Compliance Manager Projects (m/f)

Participate on assigned project and product development teams by representing
and reinforcing Design Control, Quality Assurance and Regulatory requirements
Ensure that the technical documentation supporting the CE mark complies with
MDD 93/42/EEC and prepare for MDR Regulation (EU) 2017/745
Create and maintain Technical Files/Design Dossiers
Support the International Regulatory Affairs Team in preparation of
international Submission Dossiers
Interaction with authorities, notified bodies and any other approving bodies
that will be relevant
Assessment of potential risks and the classification of the medical device in
accordance with MDD
Support and consultation of the Departments in regard of interpretation of
regulatory rules/laws/guidelines
Identify and communicate potential risks in submission and anticipate
regulatory responses through scenario planning BSc or MSc degree in a technical or natural scientific field
At least two years professional experience in Regulatory Affairs and/or Quality
Management
Detailed knowledge about the standards and directives for Medical Devices such
as ISO 13485, ISO 14971, 93/42/EEC and Regulation (EU) 2017/745
Experience from Quality Audits would be a plus
Good knowledge of English in writing and speaking, knowledge of German is a
wish; further knowledge of additional languages would be an asset
Customer-driven, solution-focused, systems-oriented and emotionally intelligent
personality We offer...
A creative, inspired and engaged team on a mission: #WeRockDentistry
The ability to take ownership for your solution field as an expert
The chance to create your footprint in the dental industry
An informal, hands-on working environment with opportunities to grow - it's fun
to work with us

Institut Straumann AG