7 days ago

Regulatory Affairs & Compliance Manager Digital (m/f)

Institut Straumann AG

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We are looking for you as our new Regulatory Affairs & Compliance Manager Digital (m/f)

In this role you will responsible for the overall registration strategies, coordination, implementation, execution control and completion of product registration, assuring compliance with regulatory requirements. The position is based in Basel, Switzerland.

Regulatory Affairs & Compliance Manager Digital (m/f)

Participate on assigned project (MDR implementation) and product development
teams by representing and reinforcing Design Control, Quality Assurance and
Regulatory Affairs requirements
Work in a multidisciplinary group for Technical File adaption according to MDR
Ensure that the technical documentation supporting the CE mark complies with
MDD 93/42/EEC
Create and maintain Technical Files/Design Dossiers
Create US and Canadian submission dossiers
Support the International Regulatory Affairs Team in preparation of
international Submissions
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 and MDR
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
Detailed knowledge about the standards and directives for Medical Devices such
as ISO 13485, ISO 14971, MDD 93/42/EEC and MDR 2017/745
Experience from Audits would be a plus
Fluency in English (in writing and speaking), further knowledge of additional
languages e.g. German would be an asset
Customer-driven, solution-focused, systems-oriented and emotionally intelligent
Advanced knowledge of excel and data analysis would be a plus Become part of a creative, inspired and engaged team on a mission:
Bring your ideas to life - create your footprint in the dental industry
You can expect an informal, hand-on working environment with opportunities to

Institut Straumann AG