Regulatory Affairs Manager - Baar, Schweiz - Medela LLC

Medela LLC

Geprüftes Unternehmen

Baar, Schweiz

vor 4 Wochen

Geschrieben von:

Lena Schneider

beBee Recruiter

Beschreibung

In this role you are involved in innovation projects to support the development team.

It is your responsibility to raise awareness in terms of regulatory affairs among the product lifecycle as well as the different departments.

You enjoy interacting with a wide variety of stakeholders in different countries and work together in a goal-oriented and professional manner.

You and your team are supporting our product line Surgical & Wound Care.

Your responsibilities:

Consultancy and active support of project teams during the development of new products and the product lifecycle in terms of questions in regards to risk management, products safety licensing as well as standards and guidance documents
Independent review of technical documentation according to specific international laws and guidance documents relevant for medical devices
Establishment and maintenance of the Regulatory Process related documentation within the product lifecycle (Medical Device Classification, Device Description, etc.)
Independent establishment of training materials and execution of employee trainings; review and release of marketing materials and labeling
Independent maintenance of the product licenses for the relevant markets
Compilation / Implementation of the relevant registration documentation of Medela products in cooperation with specific incountry contact person or specific authorities (worldwide)
Perform Pre-RA Assessment for change control activities including change reporting to worldwide Competent authorities when necessary

Your qualifications

Proven expertise of minimum 3 years in Regulatory Affairs within medical device industries
Degree in health or sciencerelated field, or equivalent
International registration experience (EU/MDSAP/China/LATAM/APAC)
Excellent verbal and written communication skills to the point
Business fluent in English, additional languages are an asset
Teamoriented, efficient as well as wellorganized way of working

Your opportunity

At Medela, you will be joining a global community of colleagues, united by the purpose that drives our business: helping people.

Medela exists to advance human health and wellbeing through knowledge-based and innovative human milk and medical vacuum solutions.

Our employees are empowered to serve this purpose in a family-owned company that is growing rapidly around the world. We value intensive exchanges, diverse perspectives, and unbureaucratic decisions.

You will have the opportunity to develop at an international level, and witness the direct impact your work has on our company's success.