Regulatory Affairs Manager

Vor 6 Tagen

Baar, Schweiz Medela LLC Vollzeit

In this role you are representing regulatory in strategic new development projects across a wide product portfolio within our Mom & Baby, NICU & Maternity Care product line. It is your responsibility to raise awareness in terms of regulatory affairs matters amongst the different departments. You will enjoy interacting with a wide variety of stakeholders in different departments and countries and work together in a goal-oriented and professional manner.

Join our Medela family. Together we turn science into care.

Your core 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, guidance documents and marketing material/ labeling
- Set, lead and implement the regulatory strategy
- 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
- Perform country registrations and re-registrations, labeling reviews/releases as well as change control assessments
- Support of testing activities in regards to the relevant standards (IEC 60601-1, EMC, environmental and packaging testing, sterilization, biocompatibility, etc.)

Your qualifications
- Degree in a health or science-related field or in Engineering (Bachelor, Master)
- Minimum 2 years of experience in the medical device industry in a similar position
- Fluency in English
- Motivation to join a young and dynamic team
- Ability to handle different topics and willingness to learn
- Demonstrate good interpersonal skills, ability to work with others in an international team environment, effective interactions in cross department teams
- Orientation for work result details, with emphasis on accuracy and completeness

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.

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