Description
On behalf my client, one of the leading medical device companies in the world with the headquarter in Zurich area,Switzerland I am recruiting for a:Regulatory affairs Consultant 100% m/f
Details & Background of the service:
With the Regulatory Affairs Re-Registrations Integration Roadmap various integration changes with impact to regulatory registrations are coordinated to minimize the regulatory impact. A team is built that supports these Regulatory Re-registrations. The position of the RA Integration Consultant for EMEA Countries works on the re-registration activities related to integration, such as Distribution Changes, Legal Manufacturer Changes or Manufacturing Transfers. These include the help on analysing the changes impact, requesting STED documentation from the Design Center and suppliers and perform the local re-registrations.
Main tasks to be delivered by the consultant:
- Performs impact assessments for integration changes and communicates with Integration Contractors at the Business Site
- Plans and coordinates work for related integration changes and working team
- Communicates with suppliers and requests registration documents including apostilled quality certificates
- Requests STED documentation from the Integration Contractors at the Business Site and external suppliers
- Performs local integration change re-registrations, or liaise with local RA contact for that purpose
- Supports handling and coordination of questions/answers from the local authorities
- Reports the re-registration progress to the Re-registration Roadmap lead Note: This is not an exhaustive list of duties or functions.
Expected qualifications of the candidate:
- University Degree in life sciences, technical (engineering) or related field
- Strong knowledge and experience with medical device 5-10 years international and EU CE-marking regulations
- Experience with medical quality system requirements according to Code of Federal Regulations and ISO 13485
- Basic project management knowledge - good coordination abilities
- Good Team player
- Strong written and verbal communication skills
- Good computer skills, including Microsoft Office Suite
- Fluency in English both verbal and written
Time period:
Min six (6) months, 100% present (Expected starting date: mid/end June)
Working time:
The work days are considered as eight (8) hours per day and five (5) days per week.
About me:
I am a specialised recruiter, currently taking care of various projects within the Life Science area in Switzerland. If this role is of interest to you or to someone from your network, please send your CV in Word including your hourly rate expectation for immediate consideration.
You can reach me on or at