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Regulatory Affairs Manager at Ypsomed

Burgdorf, Bern, Switzerland -

Full Time

Start Date

Immediate

Expiry Date

02 Jan, 26

Salary

0.0

Posted On

04 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Medical Devices, Active Medical Devices, US Regulations, Organizational Skills, Team Player, Communication Skills, Stakeholder Management, Quality Management, Product Submission, Authority Audits, Q-documents, Training, Engineering, Natural Sciences, Medical Sciences

Industry

Medical Equipment Manufacturing

Description

Your main tasks Focus of this position is supporting our rapidly developing in Diabetes Care (active and connected devices) Manage the development and implementation of RA strategies Support and prepare product submission documents with main focus on US Partner with business stakeholders on different levels Communication and correspondence with authorities Cooperation in authority audits General QM tasks (Creation of Q-documents, trainings etc.) Your profile University degree preferably in Engineering or Natural/Medical Sciences or equivalent experience At least 5 years of professional experience in Regulatory Affairs with focus medical device Expertise in Active Medical Devices related regulations and guidance documents in US Excellent organizational and people skills Strong team player Strong communicator at a high stakeholder level Very good English knowledge (Level C2 or MT)

Responsibilities

The Regulatory Affairs Manager will support the development of strategies for Diabetes Care products and manage product submission documents primarily for the US market. This role involves communication with authorities and cooperation during audits.